A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

• ClinicalTrials.gov Identifier: NCT00856544
• Recruitment Status: Completed
• First Posted: March 5, 2009
• Results First Posted: January 10, 2013
• Last Update Posted: January 10, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid
• Interventions: Drug: CP-690,550; Drug: Placebo
• Enrollment: 795

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Period Title: Overall Study
Started	318	318	79	80
Treated	315	318	79	80
Completed	261	252	71	67
Not Completed	57	66	8	13
Reason Not Completed
Randomized but not treated	3	0	0	0
Death	0	2	0	0
Adverse Event	20	29	2	3
Lack of Efficacy	16	12	3	3
Other	9	16	1	6
Lost to Follow-up	1	2	2	0
Withdrawal by Subject	8	5	0	1

Baseline Characteristics

Arm/Group Title		CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg	Total
Arm/Group Description		CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.	Total of all reporting groups
Overall Number of Baseline Participants		315	318	79	80	792
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	315 participants	318 participants	79 participants	80 participants	792 participants
		52.7 (11.7)	51.9 (11.8)	50.8 (11.2)	53.3 (10.8)	52.3 (11.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	315 participants	318 participants	79 participants	80 participants	792 participants
	Female	264 83.8%	258 81.1%	63 79.7%	60 75.0%	645 81.4%
	Male	51 16.2%	60 18.9%	16 20.3%	20 25.0%	147 18.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Description	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	157
Measure Type: Number; Unit of Measure: percentage of participants
	52.73	58.25	31.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
	Method	Normal approximation
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	27.04
	Confidence Interval	(2-Sided) 95%; 17.94 to 36.13
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
	Method	Normal Approximation
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	21.52
	Confidence Interval	(2-Sided) 95%; 12.39 to 30.65
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	315	157
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n= 311, 315, 157)	1.44 (0.69)	1.43 (0.68)	1.35 (0.66)
Change at Month 3 (n= 292, 292, 147)	-0.45 (0.53)	-0.54 (0.60)	-0.16 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95%; -0.44 to -0.26
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.16
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	[Not Specified]

3. Primary Outcome

Title	Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
Description	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	263	270	148
Measure Type: Number; Unit of Measure: percentage of participants
	9.13	13.33	2.70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.
	Method	Normal Approximation
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	10.63
	Confidence Interval	(2-Sided) 95%; 5.80 to 15.45
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0038
	Comments	A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.
	Method	Normal Approximation
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	6.42
	Confidence Interval	(2-Sided) 95%; 2.07 to 10.77
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	157
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	27.33	32.25	10.90
Month 1	38.59	48.54	22.93
Month 2	54.02	64.40	26.11
Month 3	56.27	64.72	27.39
Month 4.5	50.80	57.93	25.48
Month 6	52.73	58.25	31.21

5. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	79	78
Measure Type: Number; Unit of Measure: percentage of participants
Month 9	50.48	62.14	37.97	34.62
Month 12	51.45	56.63	31.65	34.62

6. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Description	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	157
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	5.79	8.14	1.28
Month 1	11.58	18.12	1.27
Month 2	23.15	29.77	4.46
Month 3	27.33	33.98	9.55
Month 4.5	27.97	33.33	8.28
Month 6	33.76	36.57	12.74

7. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Description	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	79	78
Measure Type: Number; Unit of Measure: percentage of participants
Month 9	31.51	43.04	25.32	26.92
Month 12	33.44	42.72	24.05	25.64

8. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Description	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	157
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	0.32	2.28	0.00
Month 1	3.54	7.12	0.00
Month 2	9.00	10.36	1.27
Month 3	8.36	14.24	1.91
Month 4.5	11.90	18.12	3.18
Month 6	13.18	16.18	3.18

9. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
Description	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	309	79	78
Measure Type: Number; Unit of Measure: percentage of participants
Month 9	14.15	25.24	10.13	11.54
Month 12	19.29	25.57	13.92	20.51

10. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Description	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	312	315	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n=312, 315, 158)	5.21 (0.92)	5.26 (0.96)	5.22 (0.92)
Week 2 (n=309, 304, 156)	4.41 (1.10)	4.18 (1.09)	4.92 (1.01)
Month 1 (n=304, 300, 151)	4.08 (1.13)	3.83 (1.12)	4.68 (1.09)
Month 2 (n=294, 300, 148)	3.70 (1.20)	3.49 (1.15)	4.59 (1.16)
Month 3 (n=293, 291, 147)	3.62 (1.22)	3.44 (1.15)	4.51 (1.15)
Month 4.5 (n=281,286,71)	3.46 (1.27)	3.15 (1.12)	3.92 (1.18)
Month 6 (n=279,278,68)	3.39 (1.21)	3.09 (1.13)	3.60 (1.12)

11. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Description	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	267	263	72	68
Mean (Standard Deviation); Unit of Measure: units on a scale
Month 9	3.21 (1.14)	2.88 (1.05)	3.22 (1.05)	2.83 (0.93)
Month 12	3.08 (1.19)	2.81 (1.04)	3.03 (1.15)	2.99 (1.06)

12. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
Description	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	309	313	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n=309,313,158)	6.29 (0.96)	6.36 (1.01)	6.30 (0.92)
Month 3 (n=206,263,140)	4.41 (1.39)	4.20 (1.30)	5.32 (1.26)
Month 6 (n=241,248,62)	4.14 (1.34)	3.84 (1.26)	4.34 (1.19)

13. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
Description	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	220	226	63	62
Mean (Standard Deviation); Unit of Measure: units on a scale
	3.82 (1.30)	3.50 (1.11)	3.76 (1.31)	3.62 (1.19)

14. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Description	DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12

Outcome Measure Data

Analysis Population Description

Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Description	DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 3, 6, 12

Outcome Measure Data

Analysis Population Description

Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

16. Secondary Outcome

Title	Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	315	157
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n = 311, 315, 157)	1.44 (0.69)	1.43 (0.68)	1.35 (0.66)
Week 2 (n = 310, 305, 156)	1.24 (0.69)	1.14 (0.67)	1.28 (0.66)
Month 1 (n = 304, 303, 154)	1.12 (0.67)	1.01 (0.65)	1.20 (0.67)
Month 2 (n = 299, 300, 150)	1.03 (0.68)	0.93 (0.66)	1.20 (0.63)
Month 3 (n = 293, 292, 148)	0.98 (0.67)	0.88 (0.67)	1.16 (0.67)
Month 4.5 (n = 282, 289, 71)	0.97 (0.68)	0.84 (0.67)	0.95 (0.62)
Month 6 (n = 278, 279, 68)	0.91 (0.67)	0.81 (0.65)	0.93 (0.61)

17. Secondary Outcome

Title	Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame	Month 9, Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	266	264	72	70
Mean (Standard Deviation); Unit of Measure: units on a scale
Month 9	0.89 (0.68)	0.71 (0.64)	0.85 (0.65)	0.70 (0.64)
Month 12	0.86 (0.68)	0.73 (0.64)	0.81 (0.68)	0.73 (0.69)

18. Secondary Outcome

Title	Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Description	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	315	158
Mean (Standard Deviation); Unit of Measure: mm
Baseline (n = 311, 315, 158)	57.08 (23.82)	58.58 (22.19)	57.11 (22.84)
Week 2 (n = 310, 306, 156)	46.81 (22.82)	41.85 (22.49)	51.01 (24.45)
Month 1 (n = 304, 303, 154)	40.17 (23.20)	37.08 (22.14)	45.69 (25.00)
Month 2 (n = 299, 301, 150)	36.40 (22.63)	32.84 (21.71)	47.30 (24.29)
Month 3 (n = 294, 292, 148)	34.92 (23.03)	32.96 (23.10)	46.59 (27.14)
Month 4.5 (n = 284, 289, 71)	34.43 (22.68)	32.62 (21.74)	40.23 (24.44)
Month 6 (n = 279, 280, 68)	31.07 (21.84)	29.94 (21.53)	34.19 (21.69)

19. Secondary Outcome

Title	Patient Assessment of Arthritis Pain at Month 9 and 12
Description	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	267	264	72	70
Mean (Standard Deviation); Unit of Measure: mm
Month 9	30.78 (22.28)	27.13 (20.77)	29.50 (21.34)	25.26 (21.96)
Month 12	30.18 (23.11)	25.43 (20.57)	28.20 (22.46)	25.39 (22.71)

20. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Description	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	315	158
Mean (Standard Deviation); Unit of Measure: mm
Baseline (n=311,315,158)	59.03 (22.89)	60.22 (22.53)	57.92 (23.33)
Week 2 (n=310,306,156)	46.59 (22.52)	42.99 (22.16)	51.27 (23.97)
Month 1 (n=303,303,154)	40.50 (23.29)	36.53 (21.42)	46.25 (24.22)
Month 2 (n=299,301,150)	37.18 (22.52)	33.80 (22.21)	50.42 (23.56)
Month 3 (n=294,292,148)	36.27 (22.64)	33.43 (22.55)	47.09 (26.13)
Month 4.5 (n=284,289,71)	35.92 (22.69)	34.05 (22.09)	41.03 (23.75)
Month 6 (n=279,280,68)	33.75 (23.01)	31.31 (21.55)	35.47 (20.28)

21. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Description	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	266	264	72	70
Mean (Standard Deviation); Unit of Measure: mm
Month 9	32.06 (22.49)	28.01 (20.81)	28.97 (20.07)	28.56 (22.74)
Month 12	30.64 (22.03)	27.94 (20.39)	28.71 (23.05)	28.20 (24.29)

22. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Description	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	310	313	158
Mean (Standard Deviation); Unit of Measure: mm
Baseline (n=310,313,158)	60.48 (17.83)	59.66 (17.03)	58.87 (16.52)
Week 2 (n=308,304,155)	46.41 (20.14)	43.79 (18.17)	49.08 (18.90)
Month 1 (n=302,303,154)	38.35 (19.92)	34.31 (18.70)	42.86 (20.13)
Month 2 (n=299,299,150)	32.54 (19.36)	29.40 (17.36)	41.25 (20.42)
Month 3 (n=293,292,148)	31.97 (20.25)	29.21 (19.31)	39.54 (21.09)
Month 4.5 (n=283,288,71)	29.45 (19.84)	26.11 (17.54)	33.04 (21.06)
Month 6 (n=278,280,68)	25.83 (17.29)	23.69 (16.62)	27.88 (19.10)

23. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Description	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	265	264	72	70
Mean (Standard Deviation); Unit of Measure: mm
Month 9	24.36 (17.67)	20.09 (14.23)	22.70 (15.42)	20.63 (17.35)
Month 12	21.52 (17.14)	18.12 (14.50)	19.01 (15.01)	17.59 (15.21)

24. Secondary Outcome

Title	36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Description	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	312	315	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline:physical functioning(n=312,315,158)	32.53 (9.58)	31.74 (9.62)	32.76 (9.59)
Baseline:role physical(n=312,315,158)	33.73 (9.74)	33.15 (9.43)	33.91 (9.57)
Baseline:social functioning(n=312,315,158)	36.22 (11.15)	37.04 (10.27)	36.87 (11.63)
Baseline:bodily pain(n=312,315,158)	33.38 (7.25)	33.94 (7.28)	34.22 (7.47)
Baseline:mental health(n=312,315,158)	39.94 (12.52)	41.05 (10.54)	41.50 (11.38)
Baseline:role emotional(n=312,315,158)	35.51 (13.65)	34.91 (13.00)	35.36 (12.97)
Baseline:vitality(n=312,315,158)	40.84 (10.29)	40.87 (8.89)	41.33 (9.37)
Baseline:general health(n=312,315,158)	33.95 (9.14)	34.27 (8.58)	34.65 (8.32)
Baseline:mental component(n=312,315,158)	40.86 (12.59)	41.56 (11.14)	41.67 (11.57)
Baseline:physical component(n=312,315,158)	32.44 (7.82)	32.02 (7.46)	32.74 (7.60)
Month 1:physical functioning(n=303,302,154)	36.17 (10.33)	36.71 (10.08)	33.95 (9.72)
Month 1:role physical(n=303,301,154)	38.20 (10.33)	39.00 (9.60)	37.15 (9.41)
Month 1:social functioning(n=303,302,154)	40.25 (10.99)	41.96 (9.73)	39.29 (9.92)
Month 1:bodily pain(n=303,302,154)	39.02 (7.86)	40.70 (7.69)	36.87 (7.14)
Month 1:mental health(n=303,302,153)	43.40 (11.43)	44.70 (10.00)	42.79 (11.04)
Month 1:role emotional(n=303,301,154)	38.36 (12.79)	39.27 (11.91)	38.18 (12.97)
Month 1:vitality(n=303,302,153)	45.87 (10.17)	46.71 (8.76)	43.74 (9.00)
Month 1:general health(n=303,302,154)	37.86 (9.45)	38.81 (8.65)	36.39 (8.35)
Month 1:mental component(n=303,301,153)	44.04 (11.64)	45.32 (10.13)	43.80 (11.22)
Month 1:physical component(n=303,301,153)	37.12 (8.31)	37.94 (7.96)	34.86 (7.48)
Month 3:physical functioning(n=294,291,147)	37.15 (10.47)	38.29 (10.60)	34.35 (10.42)
Month 3:role physical(n=294,292,147)	39.25 (9.91)	40.57 (9.69)	36.50 (9.76)
Month 3:social functioning(n=294,292,147)	41.51 (10.46)	42.44 (9.92)	38.62 (11.04)
Month 3:bodily pain(n=294,292,147)	40.22 (8.24)	41.82 (8.70)	37.50 (8.26)
Month 3:mental health(n=294,292,147)	44.69 (10.45)	45.15 (10.28)	42.68 (10.88)
Month 3:role emotional(n=293,291,146)	38.36 (11.98)	39.81 (12.04)	37.42 (13.23)
Month 3:vitality(n=294,292,147)	47.05 (9.71)	47.22 (9.05)	43.84 (9.68)
Month 3:general health(n=294,291,147)	38.98 (9.69)	39.45 (9.19)	35.56 (9.37)
Month 3:mental component(n=293,290,146)	44.96 (10.75)	45.35 (10.26)	43.10 (11.12)
Month 3:physical component(n=293,290,146)	38.26 (8.46)	39.53 (8.58)	34.90 (8.37)
Month 6:physical functioning(n=279,280,68)	38.55 (10.60)	39.42 (10.38)	38.18 (9.63)
Month 6:role physical(n=279,279,68)	39.86 (9.82)	41.02 (9.41)	40.27 (8.86)
Month 6:social functioning(n=279,280,68)	41.97 (10.22)	43.36 (10.01)	43.67 (9.96)
Month 6:bodily pain(n=279,280,68)	41.01 (8.17)	42.12 (8.45)	41.91 (7.74)
Month 6:mental health(n=279,280,68)	44.43 (10.26)	45.01 (10.27)	44.12 (10.13)
Month 6:role emotional(n=279,279,68)	39.37 (12.11)	40.49 (11.79)	39.81 (12.38)
Month 6:vitality(n=279,280,68)	47.02 (9.82)	47.80 (9.55)	46.67 (8.93)
Month 6:general health(n=279,280,68)	40.03 (9.51)	39.71 (9.17)	38.10 (9.05)
Month 6:mental component(n=279,279,68)	44.73 (10.59)	45.63 (10.29)	45.13 (11.02)
Month 6:physical component(n=279,279,68)	39.49 (8.64)	40.24 (8.43)	39.24 (7.19)

25. Secondary Outcome

Title	36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Description	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	267	264	72	70
Mean (Standard Deviation); Unit of Measure: units on a scale
Month 9:physical functioning(n=267,263,72,70)	39.40 (10.60)	40.67 (10.12)	38.86 (10.47)	40.83 (9.76)
Month 9:role physical(n=267,263,72,70)	40.21 (9.99)	42.03 (9.05)	41.44 (9.70)	42.99 (9.18)
Month 9:social functioning(n=267,264,72,70)	42.43 (9.97)	43.67 (9.60)	43.26 (11.23)	44.11 (10.32)
Month 9:bodily pain(n=267,264,72,70)	41.83 (8.89)	43.37 (8.45)	42.31 (8.42)	44.03 (8.26)
Month 9:mental health(n=267,264,72,70)	45.49 (10.69)	46.03 (10.67)	46.12 (10.49)	45.11 (10.51)
Month 9:role emotional(n=267,264,72,70)	40.55 (11.54)	42.16 (11.43)	40.75 (12.67)	41.02 (11.46)
Month 9:vitality(n=267,264,72,70)	48.39 (9.53)	48.70 (9.41)	48.38 (8.71)	47.29 (10.43)
Month 9:general health(n=266,264,72,70)	39.77 (9.63)	40.57 (9.29)	40.38 (9.04)	40.08 (9.50)
Month 9:mental component(n=266,262,72,70)	45.97 (10.45)	46.61 (10.74)	46.42 (11.01)	45.22 (11.40)
Month 9:physical component(n=266,262,72,70)	39.79 (8.60)	41.15 (8.15)	40.07 (7.97)	42.05 (6.93)
Month 12:physical functioning(n=258, 250,70,67)	39.07 (11.18)	40.38 (10.24)	38.61 (11.38)	39.85 (10.97)
Month 12:role physical(n=258, 250,70,67)	40.51 (9.99)	42.11 (9.31)	42.51 (9.72)	43.16 (9.51)
Month 12:social functioning(n=258, 250,70,67)	42.69 (10.14)	43.63 (9.71)	44.27 (9.72)	44.36 (10.30)
Month 12:bodily pain(n=258, 250,70,67)	41.95 (8.77)	43.28 (8.70)	42.59 (9.07)	45.49 (8.11)
Month 12:mental health(n=258, 250,70,67)	44.86 (10.63)	45.52 (10.27)	46.10 (10.81)	45.65 (11.29)
Month 12:role emotional(n=258, 250,70,67)	40.02 (12.10)	41.37 (11.79)	42.92 (11.80)	42.40 (11.92)
Month 12:vitality(n=258, 250,70,67)	48.08 (9.83)	48.12 (9.22)	49.77 (9.52)	47.75 (10.45)
Month 12:general health(n=258, 250,70,67)	39.63 (9.64)	39.88 (8.88)	40.86 (9.34)	39.43 (10.35)
Month 12:mental component(n=258, 250,70,67)	45.39 (10.69)	45.92 (10.65)	47.84 (11.04)	46.33 (11.21)
Month 12:physical component(n=258, 250,70,67)	39.94 (8.83)	41.13 (8.13)	40.16 (9.14)	41.62 (8.16)

26. Secondary Outcome

Title	Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Description	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	312	314	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline:overall sleep problem(n=312,313,158)	41.05 (20.68)	40.89 (18.47)	39.75 (18.25)
Baseline:sleep problem summary(n=312,314,158)	39.51 (21.22)	40.08 (19.02)	37.87 (18.37)
Baseline:somnolence(n=312,314,158)	34.38 (21.95)	36.09 (21.59)	34.94 (17.94)
Baseline:snoring(n=310,314,157)	32.26 (30.31)	31.27 (31.27)	33.76 (32.09)
Baseline:quantity(n=312,313,158)	6.88 (2.13)	6.72 (1.55)	6.82 (1.51)
Baseline:sleep disturbance(n=312,313,158)	44.39 (26.68)	41.58 (24.61)	41.20 (25.42)
Baseline:awaken short of breath(n=312,314,158)	18.91 (24.38)	19.81 (24.38)	17.34 (21.78)
Baseline:adequacy(n=312,314,158)	47.56 (28.78)	44.97 (26.89)	46.84 (25.69)
Month 1:overall sleep problem(n=301,301,154)	36.51 (19.94)	34.77 (17.79)	37.09 (18.02)
Month 1:sleep problem summary(n=301,301,154)	35.87 (20.50)	34.45 (17.94)	35.95 (18.32)
Month 1:somnolence(n=301,302,154)	31.58 (21.01)	30.49 (20.05)	33.33 (19.02)
Month 1:snoring(n=300,302,153)	29.87 (29.33)	28.74 (30.29)	32.03 (29.68)
Month 1:quantity(n=301,301,154)	6.90 (1.54)	7.02 (1.55)	6.81 (1.54)
Month 1:sleep disturbance(n=301,302,154)	38.43 (26.01)	34.64 (24.20)	37.42 (24.86)
Month 1:awaken short of breath(n=301,301,154)	18.34 (23.41)	17.21 (21.91)	14.94 (20.01)
Month 1:adequacy(n=301,302,154)	52.92 (27.91)	51.52 (26.23)	49.16 (23.51)
Month 3:overall sleep problem(n=292,292,146)	35.10 (18.58)	34.06 (17.33)	38.66 (17.32)
Month 3:sleep problem summary(n=292,292,146)	34.41 (19.04)	33.80 (17.65)	37.97 (17.21)
Month 3:somnolence(n=292,292,146)	30.07 (19.89)	28.90 (18.75)	35.43 (20.29)
Month 3:snoring(n=290,292,144)	31.31 (29.56)	31.78 (30.23)	31.81 (29.77)
Month 3:quantity(n=293,292,147)	6.87 (1.54)	6.96 (1.46)	6.76 (1.55)
Month 3:sleep disturbance(n=292,292,146)	36.67 (23.98)	33.69 (23.01)	37.77 (24.18)
Month 3:awaken short of breath(n=292,292,146)	19.38 (24.67)	17.26 (21.19)	18.08 (21.57)
Month 3:adequacy(n=292,292,146)	54.66 (27.42)	51.58 (26.71)	45.82 (25.54)
Month 6:overall sleep problem(n=277,280,68)	33.92 (19.36)	33.11 (16.94)	34.87 (18.29)
Month 6:sleep problem summary(n=277,280,68)	33.26 (19.87)	33.30 (17.17)	34.85 (18.81)
Month 6:somnolence(n=277,280,68)	31.12 (20.03)	29.81 (18.23)	30.29 (19.19)
Month 6:snoring(n=271,280,68)	31.14 (28.98)	32.07 (29.21)	31.47 (29.79)
Month 6:quantity(n=278,279,68)	6.86 (1.52)	6.94 (1.42)	6.82 (1.41)
Month 6:sleep disturbance(n=277,280,68)	34.48 (24.11)	31.33 (21.96)	34.78 (24.36)
Month 6:awaken short of breath(n=277,280,68)	17.62 (19.89)	17.57 (20.87)	17.06 (24.98)
Month 6:adequacy(n=277,280,68)	54.40 (28.34)	51.64 (26.36)	50.29 (26.76)

27. Secondary Outcome

Title	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Description	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	312	315	158
Measure Type: Number; Unit of Measure: participants
Baseline (n=312,315,158)	139	139	70
Month 1 (n=305,303,155)	155	145	72
Month 3 (n=294,292,147)	139	152	65
Month 6 (n=278,280,145)	142	143	66

28. Secondary Outcome

Title	Medical Outcome Study (MOS) Sleep Scale at Month 12
Description	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	258	249	70	66
Mean (Standard Deviation); Unit of Measure: units on a scale
Overall sleep problem	34.17 (18.71)	32.24 (17.13)	31.74 (17.41)	33.58 (17.44)
Sleep problem summary	33.71 (19.11)	32.58 (17.42)	30.95 (17.09)	32.53 (17.89)
Somnolence	29.30 (19.09)	27.93 (17.70)	30.86 (21.18)	28.48 (15.45)
Snoring	30.32 (28.59)	32.37 (29.70)	31.43 (31.13)	31.38 (27.58)
Quantity	6.94 (1.51)	7.04 (1.30)	6.83 (1.36)	6.95 (1.42)
Sleep disturbance	34.78 (24.31)	31.75 (21.95)	29.41 (24.04)	35.63 (22.81)
Awaken short of breath	19.77 (24.38)	17.19 (21.25)	17.71 (19.42)	14.85 (17.30)
Adequacy	54.38 (26.14)	53.29 (25.26)	55.00 (25.01)	55.76 (26.37)

29. Secondary Outcome

Title	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
Description	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	258	250	70	67
Measure Type: Number; Unit of Measure: participants
	134	144	37	36

30. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
Description	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	312	314	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n=312,314,158)	29.01 (11.01)	28.65 (9.49)	29.72 (8.97)
Month 1 (n=301,302,153)	33.16 (10.75)	33.94 (8.91)	31.78 (9.58)
Month 3 (n=294,292,147)	34.38 (10.07)	34.99 (9.20)	31.41 (9.95)
Month 6 (n=277,280,68)	35.14 (9.91)	35.01 (9.45)	35.24 (9.30)

31. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Description	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	258	249	70	67
Mean (Standard Deviation); Unit of Measure: units on a scale
	35.02 (9.83)	36.34 (9.15)	36.93 (9.19)	36.07 (9.64)

32. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	311	314	158
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n=311,314,158)	0.46 (0.31)	0.48 (0.29)	0.51 (0.27)
Month 3 (n=294,291,147)	0.63 (0.24)	0.68 (0.24)	0.56 (0.28)
Month 6 (n=277,280,68)	0.66 (0.23)	0.70 (0.21)	0.65 (0.20)

33. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	258	249	70	67
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.68 (0.23)	0.70 (0.21)	0.66 (0.24)	0.69 (0.23)

34. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Description	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	164	163	90
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline:time management(n=152,149,80)	47.13 (27.40)	46.05 (27.83)	39.98 (24.44)
Baseline:physical demands(n=154,154,86)	48.08 (25.92)	50.83 (25.34)	51.88 (24.98)
Baseline:mental demands(n=158,154,83)	36.58 (26.35)	35.86 (25.72)	30.31 (24.19)
Baseline:output demands(n=153,149,79)	41.93 (27.66)	38.76 (28.34)	32.72 (25.35)
Baseline:work loss index(n=164,163,90)	11.25 (6.04)	10.76 (6.16)	9.22 (5.28)
Month 3:time management(n=139,131,69)	38.56 (30.11)	37.39 (30.53)	36.99 (28.24)
Month 3:physical demands(n=135, 32,66)	43.14 (26.03)	45.07 (30.63)	52.78 (24.73)
Month 3:mental demands(n=142,136,72)	30.43 (27.99)	31.60 (29.49)	28.15 (23.69)
Month 3:output demands(n=136,132,68)	32.23 (27.77)	33.43 (30.58)	27.33 (24.32)
Month 3:work loss index(n=145,138,73)	9.29 (6.32)	9.64 (7.10)	8.77 (5.47)
Month 6:time management(n=112,108,27)	34.43 (28.40)	35.73 (31.85)	33.77 (31.88)
Month 6:physical demands(n=114,110,24)	48.72 (29.30)	41.75 (30.91)	48.13 (32.45)
Month 6:mental demands(n=115,112,27)	25.94 (26.35)	27.98 (28.18)	22.34 (26.57)
Month 6:output demands(n=111,111,26)	28.92 (26.55)	28.98 (28.12)	29.52 (29.09)
Month 6:work loss index(n=116,114,28)	8.73 (6.26)	8.71 (6.64)	8.03 (6.64)

35. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at Month 12
Description	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	108	101	38	32
Mean (Standard Deviation); Unit of Measure: units on a scale
Time management(n=105,98,35,31)	37.01 (30.03)	35.29 (31.80)	30.82 (29.59)	36.57 (30.80)
Physical demands(n=105,97,36,28)	44.15 (27.91)	42.41 (31.59)	47.15 (30.40)	40.82 (30.86)
Mental demands(n=108,100,36,32)	27.27 (26.33)	27.42 (27.56)	20.70 (26.37)	33.05 (29.78)
Output demands(n=105,95,35,29)	26.75 (25.54)	25.67 (27.25)	22.54 (25.05)	28.43 (27.66)
Work loss index(n=108,101,38,32)	8.65 (6.12)	8.28 (6.59)	7.06 (5.81)	8.89 (6.29)

36. Secondary Outcome

Title	Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Description	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	307	313	154
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline:Seen any doctor(n=307,312,153)	1.13 (0.34)	1.11 (0.32)	1.16 (0.37)
Baseline:Treated in emergency room(n=307,313,154)	1.94 (0.24)	1.94 (0.23)	1.95 (0.22)
Baseline:Admitted for overnight stay(n=19,18,8)	0.16 (0.37)	0.22 (0.43)	0.50 (0.93)
Baseline:Hospitalization(n=307,313,154)	1.95 (0.22)	1.93 (0.26)	1.94 (0.24)
Baseline:Outpatient surgery(n=307,312,154)	1.97 (0.16)	1.98 (0.14)	1.94 (0.24)
Baseline:Non-study diagnostic test(n=307,312,154)	1.85 (0.35)	1.87 (0.33)	1.86 (0.35)
Baseline:In nursing home(n=307,312,154)	2.00 (0.06)	1.99 (0.08)	1.99 (0.11)
Baseline:Home healthcare services(n=307,312,154)	1.99 (0.10)	1.99 (0.11)	1.99 (0.11)
Baseline:Required aids/devices(n=307,311,154)	1.88 (0.33)	1.87 (0.34)	1.88 (0.33)
Baseline:Non-medical practitioner(n=307,312,154)	1.96 (0.20)	1.98 (0.14)	1.98 (0.14)
Baseline:Currently employed(n=307,312,154)	1.64 (0.48)	1.66 (0.47)	1.62 (0.49)
Baseline:Feel well enough to work(n=121,122,57)	1.88 (0.33)	1.89 (0.32)	1.79 (0.41)
Baseline:Unable to work due to RA(n=122,129,55)	1.34 (0.48)	1.25 (0.43)	1.42 (0.50)
Baseline:Lost job/retired early(n=121,116,54)	1.64 (0.48)	1.47 (0.50)	1.50 (0.50)
Baseline:Work disabled due to RA(n=126,120,53)	1.50 (0.50)	1.34 (0.48)	1.47 (0.50)
Baseline:Retired(n=132,133,59)	1.50 (0.50)	1.41 (0.49)	1.41 (0.50)
Baseline:Sick leave due to RA(n=286,278,145)	1.75 (0.43)	1.78 (0.41)	1.81 (0.39)
Baseline:Performed part time work(n=285,278,143)	1.89 (0.31)	1.89 (0.31)	1.92 (0.28)
Baseline:Performed paid work(n=287,277,144)	1.67 (0.47)	1.66 (0.47)	1.66 (0.48)
Baseline:Unable to do chores(n=305,307,153)	1.44 (0.50)	1.48 (0.50)	1.44 (0.50)
Baseline:Chores by housekeeper(n=306,312,154)	1.85 (0.36)	1.88 (0.32)	1.88 (0.32)
Baseline:Chores by family/friends(n=306,312,154)	1.49 (0.50)	1.49 (0.50)	1.48 (0.50)
Month 3:Seen any doctor(n=290,291,146)	1.38 (0.49)	1.41 (0.49)	1.36 (0.48)
Month 3:Treated in emergency room(n=290,291,146)	1.96 (0.20)	1.98 (0.15)	1.96 (0.20)
Month 3:Admitted for overnight stay(n=12,7,6)	0.25 (0.62)	0.14 (0.38)	0.33 (0.82)
Month 3:Hospitalization(n=288,291,146)	1.99 (0.12)	1.99 (0.12)	1.97 (0.16)
Month 3:Outpatient surgery(n=290,291,146)	1.98 (0.14)	1.98 (0.13)	1.96 (0.20)
Month 3:Non-study diagnostic test(n=288,291,146)	1.91 (0.29)	1.91 (0.29)	1.90 (0.30)
Month 3:In nursing home(n=290,291,146)	2.00 (0.06)	1.99 (0.08)	2.00 (0.00)
Month 3:Home healthcare services(n=289,291,146)	1.99 (0.08)	1.99 (0.12)	1.99 (0.12)
Month 3:Required aids/devices(n=288,291,146)	1.91 (0.28)	1.91 (0.29)	1.81 (0.40)
Month 3:Non-medical practitioner(n=290,291,146)	1.98 (0.14)	1.98 (0.14)	1.99 (0.08)
Month 3:Currently employed(n=289,291,146)	1.64 (0.48)	1.66 (0.48)	1.63 (0.48)
Month 3:Feel well enough to work(n=107,130,47)	1.81 (0.39)	1.75 (0.44)	1.79 (0.41)
Month 3:Unable to work due to RA(n=108,124,50)	1.43 (0.50)	1.49 (0.50)	1.46 (0.50)
Month 3:Lost job/retired early(n=109,125,49)	1.58 (0.50)	1.61 (0.49)	1.55 (0.50)
Month 3:Work disabled due to RA(n=108,123,47)	1.49 (0.50)	1.54 (0.50)	1.51 (0.51)
Month 3:Retired(n=132,129,57)	1.45 (0.50)	1.44 (0.50)	1.39 (0.49)
Month 3:Sick leave due to RA(n=265,266,139)	1.88 (0.32)	1.91 (0.28)	1.83 (0.38)
Month 3:Performed part time work(n=264,265,139)	1.94 (0.24)	1.96 (0.20)	1.94 (0.23)
Month 3:Performed paid work(n=265,266,139)	1.72 (0.45)	1.77 (0.42)	1.72 (0.45)
Month 3:Unable to do chores(n=284,286,147)	1.65 (0.48)	1.71 (0.46)	1.57 (0.50)
Month 3:Chores by housekeeper(n=289,290,146)	1.90 (0.31)	1.93 (0.25)	1.93 (0.25)
Month 3:Chores by family/friends(n=288,290,146)	1.65 (0.48)	1.68 (0.47)	1.59 (0.49)
Month 6:Seen any doctor(n=275,279,68)	1.40 (0.49)	1.37 (0.48)	1.43 (0.50)
Month 6:Treated in emergency room(n=275,279,68)	1.95 (0.21)	1.98 (0.15)	1.97 (0.17)
Month 6:Admitted for overnight stay (n=13,5,2)	0.62 (0.87)	0.40 (0.89)	0.00 (0.00)
Month 6:Hospitalization(n=274,279,68)	1.97 (0.17)	1.97 (0.16)	2.00 (0.00)
Month 6:Outpatient surgery(n=275,279,68)	1.98 (0.13)	1.98 (0.13)	1.93 (0.26)
Month 6:Non-study diagnostic test(n=274,279,68)	1.91 (0.29)	1.93 (0.25)	1.85 (0.36)
Month 6:In nursing home(n=275,279,68)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Month 6:Home healthcare services(n=273,278,68)	1.99 (0.09)	1.99 (0.08)	2.00 (0.00)
Month 6:Required aids/devices(n=274,278,68)	1.91 (0.28)	1.91 (0.29)	1.93 (0.26)
Month 6:Non-medical practitioner(n=275,279,68)	1.99 (0.10)	2.00 (0.06)	2.00 (0.00)
Month 6:Currently employed(n=274,279,68)	1.65 (0.48)	1.66 (0.47)	1.65 (0.48)
Month 6:Feel well enough to work(n=117,129,25)	1.80 (0.40)	1.71 (0.46)	1.72 (0.46)
Month 6:Unable to work due to RA(n=121,126,23)	1.45 (0.50)	1.49 (0.50)	1.43 (0.51)
Month 6:Lost job/retired early(n=118,125,23)	1.63 (0.49)	1.57 (0.50)	1.52 (0.51)
Month 6:Work disabled due to RA(n=117,125,23)	1.53 (0.50)	1.57 (0.50)	1.65 (0.49)
Month 6:Retired(n=129,136,30)	1.47 (0.50)	1.50 (0.50)	1.47 (0.51)
Month 6:Sick leave due to RA(n=250,255,59)	1.92 (0.28)	1.95 (0.23)	1.93 (0.52)
Month 6:Performed part time work(n=250,255,59)	1.97 (0.17)	1.97 (0.17)	1.98 (0.13)
Month 6:Performed paid work(n=249,255,59)	1.78 (0.41)	1.81 (0.39)	1.76 (0.43)
Month 6:Unable to do chores(n=269,276,67)	1.70 (0.46)	1.73 (0.45)	1.69 (0.47)
Month 6:Chores by housekeeper(n=275,277,68)	1.90 (0.30)	1.95 (0.22)	1.91 (0.29)
Month 6:Chores by family/friends(n=274,277,68)	1.71 (0.46)	1.75 (0.43)	1.79 (0.41)

37. Secondary Outcome

Title	Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Description	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	254	246	70	66
Mean (Standard Deviation); Unit of Measure: units on a scale
Seen any doctor(n=254,243,70,66)	1.48 (0.50)	1.44 (0.50)	1.40 (0.49)	1.50 (0.50)
Treated in ER(n=254,246,70,67)	1.95 (0.22)	1.95 (0.22)	1.91 (0.28)	1.93 (0.26)
Admitted for overnight stay (n=13,12,6,5)	0.23 (0.60)	0.25 (0.62)	0.33 (0.82)	0.00 (0.00)
Hospitalization(n=254,246,70,67)	1.97 (0.17)	1.97 (0.16)	1.99 (0.16)	1.97 (0.12)
Had outpatient surgery(n=253,246,70,67)	1.97 (0.18)	1.98 (0.14)	1.97 (0.17)	1.97 (0.17)
Diagnostic test(n=253,246,70,67)	1.87 (0.33)	1.90 (0.30)	1.91 (0.28)	1.84 (0.37)
In nursing home(n=254,245,70,67)	1.98 (0.12)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Home healthcare services(n=252,246,70,67)	2.00 (0.06)	2.00 (0.06)	1.99 (0.12)	2.00 (0.00)
Required aids/devices(n=254,246,70,67)	1.92 (0.28)	1.93 (0.25)	1.94 (0.23)	1.93 (0.26)
Non-medical practitioner(n=254,246,70,67)	1.99 (0.09)	1.99 (0.11)	1.96 (0.20)	2.00 (0.00)
Currently employed(n=254,246,70,67)	1.66 (0.47)	1.65 (0.48)	1.50 (0.50)	1.63 (0.49)
Feel well enough to work(n=102,107,18,19)	1.74 (0.44)	1.64 (0.48)	1.72 (0.46)	1.74 (0.45)
Unable to work due to RA(n=100,107,19,19)	1.50 (0.50)	1.54 (0.50)	1.37 (0.50)	1.63 (0.50)
Lost job/retired early(n=99,103,18,19)	1.62 (0.49)	1.55 (0.50)	1.56 (0.51)	1.58 (0.51)
Work disabled due to RA(n=103,106,18,19)	1.57 (0.50)	1.56 (0.50)	1.39 (0.50)	1.58 (0.51)
Retired(n=114,117,22,22)	1.42 (0.50)	1.44 (0.50)	1.36 (0.49)	1.32 (0.48)
Sick leave due to RA(n=223,215,65,59)	1.93 (0.25)	1.94 (0.24)	1.98 (0.12)	1.93 (0.25)
Performed part time work(n=224,217,64,57)	1.96 (0.19)	1.97 (0.18)	1.98 (0.13)	1.96 (0.19)
Performed paid work(n=224,222,64,57)	1.78 (0.41)	1.76 (0.43)	1.72 (0.45)	1.75 (0.43)
Unable to do chores(n=250,246,69,66)	1.73 (0.44)	1.77 (0.42)	1.74 (0.44)	1.89 (0.31)
Chores by housekeeper(n=254,246,70,67)	1.91 (0.29)	1.96 (0.19)	2.00 (0.00)	1.93 (0.26)
Chores by family/friends(n=253,246,70,66)	1.75 (0.43)	1.80 (0.40)	1.79 (0.41)	1.82 (0.39)

38. Secondary Outcome

Title	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	266	280	130
Mean (Standard Deviation); Unit of Measure: events
Baseline:Doctor visit(n=266,280,130)	4.27 (3.99)	4.17 (3.58)	4.13 (3.80)
Baseline:RA related doctor visit(n=266,280,130)	1.33 (0.85)	1.32 (0.71)	1.25 (0.61)
Baseline:Hospital ER visit(n=19,18,8)	1.26 (0.81)	1.28 (0.67)	1.38 (0.74)
Baseline:RA related ER visit(n=19,18,8)	0.58 (0.77)	0.50 (0.51)	0.88 (0.83)
Baseline:Hospitalization(n=16,23,9)	1.50 (2.00)	1.26 (0.45)	1.22 (0.67)
Baseline:RA related hospitalization(n=16,23,9)	0.94 (0.68)	1.09 (0.90)	0.78 (0.67)
Baseline:Outpatient surgery(n=8,6,9)	1.13 (0.35)	1.17 (0.41)	1.33 (0.50)
Baseline:RA related outpatient surgery(n=8,5,9)	0.88 (0.64)	0.20 (0.45)	0.56 (0.88)
Baseline:Non-study diagnostic test(n=45,39,22)	1.64 (1.03)	2.13 (2.34)	1.64 (0.95)
Baseline:RA related diagnostic test(n=45,40,22)	0.80 (0.87)	0.90 (0.98)	0.73 (0.88)
Baseline:Non-medical practitioner visit(n=13,6,3)	8.08 (7.90)	2.83 (1.83)	8.00 (2.00)
Baseline:RA related non-medical visit(n=13,6,3)	1.23 (0.73)	1.00 (0.89)	1.33 (0.58)
Month 3:Doctor visit(n=183,174,94)	4.50 (4.18)	4.05 (3.77)	4.66 (4.94)
Month 3:RA related doctor visit(n=183,174,94)	1.06 (0.75)	0.97 (0.72)	1.03 (0.71)
Month 3:Hospital ER visit(n=11,7,6)	1.36 (0.92)	1.00 (0.00)	1.17 (0.41)
Month 3:RA related ER visit(n=12,7,6)	0.17 (0.39)	0.29 (0.76)	0.00 (0.00)
Month 3:Hospitalization(n=4,4,4)	1.00 (0.00)	1.00 (0.00)	0.75 (0.50)
Month 3:RA related hospitalization(n=4,4,4)	0.25 (0.50)	0.50 (0.58)	0.25 (0.50)
Month 3:Outpatient surgery(n=6,5,6)	2.17 (1.94)	1.00 (0.00)	1.00 (0.00)
Month 3:RA related outpatient surgery(n=6,5,6)	0.00 (0.00)	0.00 (0.00)	0.17 (0.41)
Month 3:Non-study diagnostic test(n=24,26,15)	1.63 (1.21)	1.35 (0.63)	1.33 (0.82)
Month 3:RA related diagnostic test(n=26,27,15)	0.23 (0.65)	0.22 (0.51)	0.47 (0.52)
Month 3:Non-medical practitioner visit(n=6,6,1)	4.00 (2.28)	3.00 (3.52)	40.00 [1] (NA)
Month 3:RA related non-medical visit(n=6,6,1)	0.67 (1.03)	0.67 (0.52)	4.00 [1] (NA)
Month 6:Doctor visit(n=168,178,39)	3.54 (3.87)	3.07 (2.73)	3.08 (3.96)
Month 6:RA related doctor visit(n=168,177,39)	0.91 (0.65)	0.97 (0.71)	0.74 (0.59)
Month 6:Hospital ER visit(n=13,4,2)	1.31 (0.63)	1.00 (0.00)	2.50 (2.12)
Month 6:RA related ER visit(n=13,6,2)	0.08 (0.28)	0.00 (0.00)	0.00 (0.00)
Month 6:Hospitalization(n=8,5,2)	1.13 (0.35)	1.00 (0.00)	1.00 (0.00)
Month 6:RA related hospitalization(n=8,7,2)	0.38 (0.74)	0.29 (0.76)	1.00 (0.00)
Month 6:Outpatient surgery(n=5,5,5)	1.00 (0.00)	1.40 (0.55)	1.00 (0.00)
Month 6:RA related outpatient surgery(n=5,5,5)	0.00 (0.00)	0.00 (0.00)	0.20 (0.45)
Month 6:Non-study diagnostic test(n=23,20,9)	2.04 (1.49)	1.60 (1.10)	1.11 (0.33)
Month 6:RA related diagnostic test(n=25,20,10)	0.28 (0.54)	0.35 (0.67)	0.20 (0.42)
Month 6:Non-medical practitioner visit(n=3,1,1)	12.67 (11.02)	12.00 [1] (NA)	NA [2] (NA)
Month 6:RA related non-medical visit(n=3,1,1)	0.33 (0.58)	4.00 [1] (NA)	NA [2] (NA)

[1]

Standard deviation was not estimable as only 1 participant was evaluable.

[2]

Data was not analyzed as no participant was evaluable for this parameter

39. Secondary Outcome

Title	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	136	139	42	34
Mean (Standard Deviation); Unit of Measure: events
Doctor visit(n=136,139,42,34)	3.17 (3.59)	2.58 (2.62)	3.19 (4.58)	2.62 (1.65)
RA related doctor visit (n=136,139,42,34)	0.89 (0.66)	0.74 (0.64)	1.05 (0.82)	0.79 (0.69)
Hospital ER visit(n=13,12,6,5)	1.15 (0.38)	1.17 (0.58)	1.67 (1.63)	1.00 (0.00)
RA related ER visit(n=13,12,6,5)	0.15 (0.55)	0.33 (0.65)	0.33 (0.82)	0.00 (0.00)
Hospitalization(n=7,8,1,2)	1.00 (0.00)	1.00 (0.00)	1.00 [1] (NA)	1.50 (0.71)
RA related hospitalization(n=8,8,1,2)	0.50 (0.93)	0.63 (0.92)	0.00 [1] (NA)	0.00 (0.00)
Outpatient surgery(n=4,5,2,2)	1.25 (0.50)	1.60 (1.34)	1.00 (0.00)	1.00 (0.00)
RA related outpatient surgery(n=8,5,2,2)	0.13 (0.35)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Non-study diagnostic test(n=30,25,6,9)	1.67 (0.88)	1.68 (1.44)	1.33 (0.52)	2.00 (0.87)
RA related diagnostic test(n=32,25,6,11)	0.34 (0.70)	0.12 (0.33)	0.00 (0.00)	0.09 (0.30)
Non-medical practitioner visit(n=2,2,3,0)	3.00 (1.41)	6.00 (2.83)	3.00 (2.65)	NA [2] (NA)
RA related non-medical visit(n=2,3,3,0)	0.00 (0.00)	0.67 (0.58)	0.67 (0.58)	NA [2] (NA)

[1]

Standard deviation was not estimable as only 1 participant was evaluable.

[2]

Data was not analyzed as no participant was evaluable for this parameter.

40. Secondary Outcome

Title	Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	154	158	78
Mean (Standard Deviation); Unit of Measure: days
Baseline:Hospital length of stay(n=16,23,8)	12.69 (6.05)	15.26 (13.03)	14.50 (15.97)
Baseline:Days in nursing home(n=1,2,1)	28.00 [1] (NA)	14.50 (0.71)	21.00 [1] (NA)
Baseline:Days aids/devices used(n=37,40,19)	84.92 (71.64)	100.78 (109.26)	65.37 (74.55)
Baseline:RA related aids used(n=37,42,19)	1.65 (1.18)	1.90 (1.36)	1.42 (0.84)
Baseline:Days of work per week(n=110,106,59)	5.02 (1.05)	5.01 (0.88)	4.86 (1.02)
Baseline:Days on sick leave due to RA(n=71,61,27)	27.06 (33.38)	30.26 (35.56)	31.41 (32.27)
Baseline:Days of part time work(n=30,29,12)	22.77 (28.95)	20.86 (29.44)	34.83 (34.89)
Baseline:Paid work, bothered by RA(n=94,93,48)	40.11 (30.69)	39.26 (29.85)	43.15 (32.11)
Baseline:Chores by housekeeper(n=46,37,18)	27.17 (35.34)	19.73 (28.01)	37.28 (38.31)
Baseline:Chores by family(n=154,158,79)	41.26 (38.38)	34.92 (33.94)	37.81 (35.78)
Month 3:Hospital length of stay(n=4,4,4)	7.00 (4.24)	8.25 (2.99)	3.75 (0.50)
Month 3:Days in nursing home(n=1,2,0)	10.00 [1] (NA)	14.00 (9.90)	NA [2] (NA)
Month 3:Days aids/devices used(n=24,28,28)	104.96 (87.40)	104.36 (128.12)	120.75 (152.78)
Month 3:RA related aids used(n=25,28,28)	1.68 (0.95)	1.68 (1.39)	1.79 (1.69)
Month 3:Days of work per week(n=104,99,52)	5.16 (1.01)	5.12 (1.08)	4.94 (1.00)
Month 3:Days on sick leave due to RA(n=31,22,24)	28.23 (34.67)	28.45 (39.07)	24.58 (33.18)
Month 3:Days of part time work(n=16,11,8)	20.06 (28.06)	36.91 (37.77)	36.13 (31.16)
Month 3:Paid work, bothered by RA(n=75,62,38)	31.25 (33.22)	33.15 (30.42)	42.32 (31.88)
Month 3:Chores by housekeeper(n=30,19,10)	26.87 (34.10)	16.58 (26.03)	21.40 (26.42)
Month 3:Chores by family(n=97,92,60)	34.23 (34.27)	30.51 (33.93)	41.92 (36.89)
Month 6:Hospital length of stay(n=8,7,2)	9.63 (7.76)	6.43 (5.03)	13.50 (0.71)
Month 6:Days in nursing home(n=0,0,0)	NA [2] (NA)	NA [2] (NA)	NA [2] (NA)
Month 6:Days aids/devices used(n=23,26,5)	135.04 (104.11)	116.27 (130.92)	129.20 (42.11)
Month 6:RA related aids used(n=24,26,5)	1.79 (1.18)	1.85 (1.43)	1.80 (1.48)
Month 6:Days of work per week(n=92,95,24)	5.15 (1.04)	5.04 (0.94)	4.88 (0.99)
Month 6:Days on sick leave due to RA(n=21,14,4)	27.71 (36.77)	24.43 (31.00)	10.75 (13.45)
Month 6:Days of part time work(n=7,8,2)	35.43 (27.85)	28.00 (36.01)	7.50 (3.54)
Month 6:Paid work, bothered by RA(n=54,46,13)	30.80 (31.45)	31.74 (30.04)	33.31 (30.18)
Month 6:Chores by housekeeper(n=26,13,6)	22.42 (28.69)	20.92 (31.17)	43.50 (41.56)
Month 6:Chores by family(n=78,68,14)	29.53 (31.60)	24.90 (31.36)	33.93 (37.88)

[1]

Standard deviation was not estimable as only 1 participant was evaluable.

[2]

Data was not analyzed as no participant was evaluable for this parameter.

41. Secondary Outcome

Title	Number of Days as Assessed Using RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	86	84	34	23
Mean (Standard Deviation); Unit of Measure: days
Hospital length of stay(n=8,8,1,2)	8.88 (6.73)	12.38 (11.98)	2.00 [1] (NA)	1.50 (0.71)
Days in nursing home(n=4,0,0,0)	19.50 (8.35)	NA [2] (NA)	NA [2] (NA)	NA [2] (NA)
Days aids/devices used(n=19,15,4,5)	111.79 (84.57)	161.40 (382.20)	225.00 (155.88)	62.00 (75.38)
RA related aids used(n=21,16,4,5)	1.19 (1.21)	2.50 (4.76)	2.50 (1.73)	1.80 (1.30)
Days of work per week(n=86,84,34,23)	5.20 (1.03)	5.35 (0.74)	5.00 (1.10)	5.22 (0.80)
Days on sick leave due to RA(n=15,12,1,4)	36.40 (42.27)	13.58 (25.37)	20.00 [1] (NA)	31.00 (41.49)
Days of part time work(n=8,7,1,2)	14.88 (30.48)	6.71 (3.15)	24.00 [1] (NA)	52.50 (53.03)
Paid work, bothered by RA(n=49,53,18,14)	39.08 (35.44)	40.02 (33.50)	40.39 (34.19)	47.57 (39.16)
Chores by housekeeper(n=23,9,0,5)	32.17 (36.69)	17.22 (28.01)	NA [2] (NA)	6.60 (3.29)
Chores by family(n=63,48,14,12)	26.67 (32.49)	24.98 (29.88)	26.43 (32.22)	26.00 (31.05)

[1]

Standard deviation was not estimable as only 1 participant was evaluable.

[2]

Data was not analyzed as no participant was evaluable for this parameter.

42. Secondary Outcome

Title	Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	154	159	79
Mean (Standard Deviation); Unit of Measure: hours per day
Baseline:Home healthcare services (n=3,4,2)	4.67 (6.35)	2.75 (2.36)	1.50 (0.71)
Baseline:RA related home HC services(n=3,4,2)	0.67 (0.58)	1.00 (0.82)	0.50 (0.71)
Baseline:Work done(n=110,106,59)	7.84 (2.85)	7.45 (2.27)	7.24 (1.89)
Baseline:Missed work due to RA(n=30,29,12)	4.30 (4.18)	6.24 (16.81)	7.33 (8.07)
Baseline:Chores by housekeeper(n=46,37,18)	4.61 (3.96)	4.62 (2.78)	5.17 (5.15)
Baseline:Chores by family(n=154,159,79)	4.27 (4.81)	3.86 (7.09)	4.30 (5.59)
Month 3:Home healthcare services(n=2,4,2)	1.50 (0.71)	3.25 (2.06)	1.50 (0.71)
Month 3:RA related home HC services(n=2,4,2)	0.00 (0.00)	0.25 (2.50)	1.00 (1.41)
Month 3:Work done(n=104,98,53)	8.99 (7.48)	7.64 (2.20)	8.06 (4.94)
Month 3:Missed work due to RA(n=16,11,8)	3.94 (1.88)	4.18 (2.14)	3.88 (1.13)
Month 3:Chores by housekeeper(n=30,19,10)	4.17 (2.68)	3.74 (3.74)	3.30 (2.00)
Month 3:Chores by family(n=98,89,59)	3.32 (3.30)	2.98 (3.35)	4.97 (5.77)
Month 6:Home healthcare services(n=2,2,0)	17.00 (9.90)	2.00 (1.41)	NA [1] (NA)
Month 6:RA related home HC services(n=2,2,0)	1.00 (1.41)	2.00 (1.41)	NA [1] (NA)
Month 6:Work done(n=92,95,24)	8.12 (1.89)	7.53 (1.72)	8.50 (5.34)
Month 6:Missed work due to RA(n=7,8,1)	4.43 (1.62)	3.38 (1.69)	2.00 [2] (NA)
Month 6:Chores by housekeeper(n=25,13,6)	4.64 (3.01)	5.69 (6.45)	5.17 (3.13)
Month 6:Chores by family(n=77,66,14)	3.73 (3.58)	2.91 (3.30)	4.36 (2.68)

[1]

Data was not analyzed as no participant was evaluable for this parameter.

[2]

Standard deviation was not estimable as only 1 participant was evaluable.

43. Secondary Outcome

Title	Number of Hours Per Day as Assessed RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	85	85	34	24
Mean (Standard Deviation); Unit of Measure: hours per day
Home healthcare services(n=1,1,1,0)	1.00 [1] (NA)	2.00 [1] (NA)	1.00 [1] (NA)	NA [2] (NA)
RA related healthcare services(n=1,1,1,0)	0.00 [1] (NA)	2.00 [1] (NA)	1.00 [1] (NA)	NA [2] (NA)
Work done(n=85,85,34,24)	8.60 (4.00)	7.67 (1.77)	8.79 (5.85)	7.38 (1.86)
Missed work due to RA(n=8,7,1,2)	5.00 (6.21)	3.29 (1.80)	0.00 [1] (NA)	4.00 (1.41)
Chores by housekeeper(n=22,9,0,5)	4.86 (2.71)	3.89 (1.96)	NA [2] (NA)	4.40 (2.30)
Chores by family(n=62,47,14,12)	3.24 (3.26)	2.70 (2.22)	2.50 (1.40)	5.92 (8.08)

[1]

Standard deviation was not estimable as only 1 participant was evaluable.

[2]

Data was not analyzed as no participant was evaluable for this parameter.

44. Secondary Outcome

Title	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	239	238	124
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline (n=239, 238, 119)	5.03 (5.89)	4.72 (3.22)	4.55 (3.14)
Month 3 (n= 223, 229, 124)	3.74 (3.04)	3.18 (3.21)	3.97 (3.15)
Month 6 (n= 210, 224, 46)	3.40 (3.06)	2.66 (2.83)	3.24 (2.86)

45. Secondary Outcome

Title	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Description	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo Then CP-690,550 5 mg	Placebo Then CP-690,550 10 mg
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	174	180	50	50
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.79 (2.67)	2.52 (2.74)	2.84 (2.13)	3.08 (2.60)

46. Other Pre-specified Outcome

Title	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Description	Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	51	54	33
Measure Type: Number; Unit of Measure: days
	3	3	3

47. Other Pre-specified Outcome

Title	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Description	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description:	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed	51	54	33
Measure Type: Number; Unit of Measure: days
	3	3	3

Adverse Events

Time Frame

[Not Specified]

Adverse Event Reporting Description

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title

CP-690,550 5 mg (Up To Month 3)

CP-690,550 10 mg (Up To Month 3)

Placebo (Up To Month 3)

CP-690,550 5 mg (Month 3 to 6)

CP-690,550 10 mg (Month 3 to 6)

Placebo (Month 3 to 6)

Placebo, Then CP-690,550 5 mg (Month 3 to 6)

Placebo, Then CP-690,550 10 mg (Month 3 to 6)

CP-690,550 5 mg (Post Month 6)

CP-690,550 10 mg (Post Month 6)

Placebo, Then CP-690,550 5 mg (Post Month 6)

Placebo, Then CP-690,550 10 mg (Post Month 6)

Arm/Group Description

CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.

CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.

Matching placebo Film-coated tablet orally twice daily up to Month 3.

CP-690,550 5 mg twice daily from Month 3 to 6.

CP-690,550 10 mg tablet twice daily from Month 3 to 6.

Matching placebo twice daily from Month 3 to 6.

Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.

Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.

CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.

CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.

Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.

Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.

All-Cause Mortality

CP-690,550 5 mg (Up To Month 3)

CP-690,550 10 mg (Up To Month 3)

Placebo (Up To Month 3)

CP-690,550 5 mg (Month 3 to 6)

CP-690,550 10 mg (Month 3 to 6)

Placebo (Month 3 to 6)

Placebo, Then CP-690,550 5 mg (Month 3 to 6)

Placebo, Then CP-690,550 10 mg (Month 3 to 6)

CP-690,550 5 mg (Post Month 6)

CP-690,550 10 mg (Post Month 6)

Placebo, Then CP-690,550 5 mg (Post Month 6)

Placebo, Then CP-690,550 10 mg (Post Month 6)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

Serious Adverse Events

CP-690,550 5 mg (Up To Month 3)

CP-690,550 10 mg (Up To Month 3)

Placebo (Up To Month 3)

CP-690,550 5 mg (Month 3 to 6)

CP-690,550 10 mg (Month 3 to 6)

Placebo (Month 3 to 6)

Placebo, Then CP-690,550 5 mg (Month 3 to 6)

Placebo, Then CP-690,550 10 mg (Month 3 to 6)

CP-690,550 5 mg (Post Month 6)

CP-690,550 10 mg (Post Month 6)

Placebo, Then CP-690,550 5 mg (Post Month 6)

Placebo, Then CP-690,550 10 mg (Post Month 6)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

9/315 (2.86%)

8/318 (2.52%)

6/159 (3.77%)

5/315 (1.59%)

7/318 (2.20%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

7/315 (2.22%)

9/318 (2.83%)

2/79 (2.53%)

0/80 (0.00%)

Blood and lymphatic system disorders

Thrombocytopenia * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Cardiac disorders

Angina pectoris * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Bradycardia * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Cardiac failure acute * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Atrial fibrillation * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Gastrointestinal disorders

Constipation * 1

0/315 (0.00%)

1/318 (0.31%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Pancreatitis * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Colitis * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Duodenal ulcer haemorrhage * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Peritonitis * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Salivary gland calculus * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

General disorders

Chest pain * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

1/318 (0.31%)

1/79 (1.27%)

0/80 (0.00%)

Hepatobiliary disorders

Biliary dyskinesia * 1

0/315 (0.00%)

0/318 (0.00%)

1/159 (0.63%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Cholecystitis * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Biliary colic * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Bile duct stone * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Cholelithiasis * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Infections and infestations

Bronchitis * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Diabetic foot infection * 1

0/315 (0.00%)

1/318 (0.31%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Herpes zoster disseminated * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Pneumonia * 1

0/315 (0.00%)

2/318 (0.63%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Bronchiectasis * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Pulmonary tuberculosis * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Pneumonia cryptococcal * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Injury, poisoning and procedural complications

Tendon rupture * 1

0/315 (0.00%)

2/318 (0.63%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Foot fracture * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Joint dislocation * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Femur fracture * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Muscle injury * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Tendon injury * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

1/79 (1.27%)

0/80 (0.00%)

Metabolism and nutrition disorders

Hypoglycaemia * 1

0/315 (0.00%)

1/318 (0.31%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Type 2 diabetes mellitus * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Musculoskeletal and connective tissue disorders

Osteoarthritis * 1

0/315 (0.00%)

0/318 (0.00%)

1/159 (0.63%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Rheumatoid arthritis * 1

1/315 (0.32%)

0/318 (0.00%)

2/159 (1.26%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Arthralgia * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Fistula * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Foot deformity * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Fracture nonunion * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastasis * 1

0/315 (0.00%)

1/318 (0.31%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Thyroid adenoma * 1

0/315 (0.00%)

1/318 (0.31%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Breast cancer * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Nervous system disorders

Cerebrovascular accident * 1

1/315 (0.32%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Epilepsy * 1

0/315 (0.00%)

0/318 (0.00%)

1/159 (0.63%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Amnesia * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Syncope * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Transient ischaemic attack * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Reproductive system and breast disorders

Menorrhagia * 1

0/315 (0.00%)

0/318 (0.00%)

1/159 (0.63%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Asthma * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

1/315 (0.32%)

0/318 (0.00%)

0/79 (0.00%)

0/80 (0.00%)

Pulmonary hypertension * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Respiratory failure * 1

0/315 (0.00%)

0/318 (0.00%)

0/159 (0.00%)

0/315 (0.00%)

0/318 (0.00%)

0/81 (0.00%)

0/38 (0.00%)

0/40 (0.00%)

0/315 (0.00%)

1/318 (0.31%)

0/79 (0.00%)

0/80 (0.00%)

Skin and subcutaneous tissue disorders