A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT01484561
• Recruitment Status: Completed
• First Posted: December 2, 2011
• Results First Posted: April 2, 2014
• Last Update Posted: April 2, 2014
• 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: Basic Science
• Condition: Arthritis, Rheumatoid
• Interventions: Drug: CP-690,550 or Placebo; Drug: Placebo
• Enrollment: 148

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Period Title: Overall Study
Started	97	51
Completed	88	45
Not Completed	9	6
Reason Not Completed
Lack of Efficacy	3	1
Lost to Follow-up	1	0
Withdrawal by Subject	3	0
Other	1	1
Adverse Event	1	4

Baseline Characteristics

Arm/Group Title		CP-690,550/Placebo	Placebo/Placebo	Total
Arm/Group Description		Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)	Total of all reporting groups
Overall Number of Baseline Participants		97	51	148
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	97 participants	51 participants	148 participants
		51.9 (12.7)	47.3 (11.8)	50.3 (12.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	97 participants	51 participants	148 participants
	Female	75 77.3%	36 70.6%	111 75.0%
	Male	22 22.7%	15 29.4%	37 25.0%

Outcome Measures

1. Primary Outcome

Title	Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)
Description	Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	91	46
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.91; (0.88 to 0.95)	0.99; (0.94 to 1.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 90%; 0.86 to 0.98
	Estimation Comments	Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.

2. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR
Description	mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	86	45
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.96; (0.92 to 1.00)	0.92; (0.87 to 0.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 90%; 0.97 to 1.11
	Estimation Comments	ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.

3. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR
Description	mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	86	45
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.03; (0.99 to 1.07)	0.95; (0.90 to 0.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 90%; 1.02 to 1.16
	Estimation Comments	ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.

4. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)
Description	eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	92	46
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.96; (0.94 to 0.97)	1.01; (0.99 to 1.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 90%; 0.91 to 0.97
	Estimation Comments	ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.

5. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD
Description	eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.99; (0.98 to 1.01)	1.01; (0.98 to 1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 90%; 0.96 to 1.02
	Estimation Comments	ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.

6. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD
Description	eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.04; (1.02 to 1.06)	1.00; (0.97 to 1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 90%; 1.00 to 1.08
	Estimation Comments	ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.

7. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation
Description	eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	92	46
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.96; (0.95 to 0.98)	1.01; (0.99 to 1.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 90%; 0.92 to 0.98
	Estimation Comments	ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.

8. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation
Description	eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.00; (0.98 to 1.01)	1.01; (0.98 to 1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 90%; 0.97 to 1.02
	Estimation Comments	ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.

9. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation
Description	eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.03; (1.01 to 1.05)	1.00; (0.97 to 1.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 90%; 1.01 to 1.07
	Estimation Comments	ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.

10. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine
Description	Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	92	46
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.04; (1.02 to 1.06)	0.99; (0.97 to 1.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 90%; 1.02 to 1.08
	Estimation Comments	ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.

11. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine
Description	Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	1.00; (0.99 to 1.02)	1.00; (0.97 to 1.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 90%; 0.98 to 1.04
	Estimation Comments	ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.

12. Secondary Outcome

Title	Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine
Description	Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	87	44
Geometric Mean (90% Confidence Interval); Unit of Measure: fold change
	0.97; (0.95 to 0.99)	1.00; (0.98 to 1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of Adjusted Geo Mean-Fold Change
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 90%; 0.94 to 1.00
	Estimation Comments	ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.

13. Secondary Outcome

Title	Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response
Description	ACR20 response: greater than or equal to (≥)20 percent (%) 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 the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame	Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation [NRI])

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	97	51
Measure Type: Number; Unit of Measure: percentage of participants
End of Period 1 (Day 43)	57.73	21.57
End of Period 2 (Day 29)	45.36	29.41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR20 Response at End of Period 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	36.16
	Confidence Interval	(2-Sided) 90%; 23.60 to 48.73
	Parameter Dispersion	Type: Standard Error of the mean; Value: 7.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR20 Response at End of Period 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.050
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.95
	Confidence Interval	(2-Sided) 90%; 2.56 to 29.34
	Parameter Dispersion	Type: Standard Error of the mean; Value: 8.14
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description	ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
Time Frame	Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS (NRI, LOCF)

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	97	51
Measure Type: Number; Unit of Measure: percentage of participants
End of Period 1 (Day 43)	28.87	7.84
End of Period 2 (Day 29)	26.80	9.80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR50 Response at End of Period 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	21.02
	Confidence Interval	(2-Sided) 90%; 11.24 to 30.80
	Parameter Dispersion	Type: Standard Error of the mean; Value: 5.94
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR50 Response at End of Period 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	17.00
	Confidence Interval	(2-Sided) 90%; 6.92 to 27.08
	Parameter Dispersion	Type: Standard Error of the mean; Value: 6.13
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description	ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.
Time Frame	Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS (NRI, LOCF)

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	97	51
Measure Type: Number; Unit of Measure: percentage of participants
End of Period 1 (Day 43)	18.56	0.00
End of Period 2 (Day 29)	9.28	1.96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR70 Response at End of Period 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.56
	Confidence Interval	(2-Sided) 90%; 12.06 to 25.05
	Parameter Dispersion	Type: Standard Error of the mean; Value: 3.95
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	Between-group difference in ACR70 Response at End of Period 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.038
	Comments	Two-sided test at 5% significance level.
	Method	Normal approximation for proportions
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.32
	Confidence Interval	(2-Sided) 90%; 1.51 to 13.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 3.53
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])
Description	DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-1.71 (0.13)	-0.55 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.16
	Confidence Interval	(2-Sided) 90%; -1.53 to -0.78
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.23
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

17. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)
Description	DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-1.36 (0.12)	-0.89 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.028
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 90%; -0.83 to -0.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

18. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)
Description	DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	43
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.35 (0.12)	-0.34 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 90%; 0.32 to 1.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.22
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

19. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)
Description	DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	44
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-1.88 (0.14)	-0.62 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.26
	Confidence Interval	(2-Sided) 90%; -1.67 to -0.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.25
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

20. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)
Description	DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-1.46 (0.13)	-0.96 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.031
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 90%; -0.88 to -0.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.23
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

21. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)
Description	DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	42
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.42 (0.14)	-0.34 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 90%; 0.36 to 1.15
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.24
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

22. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count
Description	68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	45
Least Squares Mean (Standard Error); Unit of Measure: tender/painful joints
	-9.88 (1.16)	-5.79 (1.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.045
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.09
	Confidence Interval	(2-Sided) 90%; -7.44 to -0.74
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.02
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

23. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count
Description	68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: tender/painful joints
	-8.13 (1.02)	-8.27 (1.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.936
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90%; -2.78 to 3.06
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.76
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

24. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count
Description	68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: tender/painful joints
	1.75 (1.11)	-2.48 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.23
	Confidence Interval	(2-Sided) 90%; 1.04 to 7.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.93
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

25. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count
Description	Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	45
Least Squares Mean (Standard Error); Unit of Measure: swollen joints
	-7.07 (0.59)	-4.81 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.26
	Confidence Interval	(2-Sided) 90%; -3.96 to -0.55
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.03
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

26. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count
Description	Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: swollen joints
	-6.63 (0.64)	-5.83 (0.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.472
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 90%; -2.64 to 1.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.11
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

27. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count
Description	Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: swollen joints
	0.43 (0.59)	-1.02 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.158
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 90%; -0.24 to 3.15
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.03
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

28. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in CRP
Description	[Not Specified]
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	46
Least Squares Mean (Standard Error); Unit of Measure: mg/L
	-13.81 (2.17)	-0.08 (3.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.73
	Confidence Interval	(2-Sided) 90%; -19.87 to -7.59
	Parameter Dispersion	Type: Standard Error of the mean; Value: 3.71
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

29. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in CRP
Description	[Not Specified]
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: mg/L
	-8.37 (2.34)	0.53 (3.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.029
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.89
	Confidence Interval	(2-Sided) 90%; -15.58 to -2.21
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.04
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

30. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in CRP
Description	[Not Specified]
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: mg/L
	5.44 (1.71)	0.61 (2.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.107
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.84
	Confidence Interval	(2-Sided) 90%; -0.10 to 9.77
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.98
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

31. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)
Description	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	-23.28 (2.81)	-7.38 (3.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.90
	Confidence Interval	(2-Sided) 90%; -23.96 to -7.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.87
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

32. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in PGAA
Description	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	-16.12 (2.87)	-10.41 (4.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.251
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.70
	Confidence Interval	(2-Sided) 90%; -13.90 to 2.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.95
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

33. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in PGAA
Description	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: mm
	7.16 (2.54)	-3.03 (3.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.19
	Confidence Interval	(2-Sided) 90%; 2.87 to 17.52
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.42
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

34. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis
Description	A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	-29.83 (2.24)	-14.71 (3.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.12
	Confidence Interval	(2-Sided) 90%; -21.58 to -8.67
	Parameter Dispersion	Type: Standard Error of the mean; Value: 3.90
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

35. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis
Description	A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	-24.61 (2.76)	-22.21 (3.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.616
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.40
	Confidence Interval	(2-Sided) 90%; -10.30 to 5.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.77
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

36. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis
Description	A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
Time Frame	Day 43 of Period 1, Day 29 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	44
Least Squares Mean (Standard Error); Unit of Measure: mm
	5.22 (2.39)	-7.50 (3.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.72
	Confidence Interval	(2-Sided) 90%; 5.82 to 19.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.17
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

37. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain
Description	Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time Frame	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	46
Least Squares Mean (Standard Error); Unit of Measure: mm
	-23.53 (2.61)	-8.23 (3.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.30
	Confidence Interval	(2-Sided) 90%; -22.78 to -7.82
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.52
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

38. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain
Description	Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time Frame	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	-14.70 (2.80)	-9.08 (3.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.247
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.62
	Confidence Interval	(2-Sided) 90%; -13.62 to 2.38
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.83
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

39. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain
Description	Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time Frame	Day 43 of Period 2, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: mm
	8.83 (2.69)	-0.85 (3.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.040
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.68
	Confidence Interval	(2-Sided) 90%; 1.95 to 17.41
	Parameter Dispersion	Type: Standard Error of the mean; Value: 4.67
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

40. Secondary Outcome

Title	LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score
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	Day 1 of Period 1, Day 43 of Period 1

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	93	46
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.44 (0.06)	-0.04 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 90%; -0.56 to -0.23
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.10
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

41. Secondary Outcome

Title	LS Mean Change at End of Period 2 From Baseline HAQ-DI Score
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	Day 1 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.34 (0.05)	-0.17 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.053
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90%; -0.31 to -0.03
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.09
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

42. Secondary Outcome

Title	LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score
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	Day 43 of Period 1, Day 29 of Period 2

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description:	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Number of Participants Analyzed	90	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.09 (0.04)	-0.13 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550/Placebo, Placebo/Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	Two-sided test at 5% significance level.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 90%; 0.10 to 0.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.07
	Estimation Comments	Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	CP-690,550/Placebo	Placebo/Placebo
Arm/Group Description	Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
All-Cause Mortality
	CP-690,550/Placebo	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	CP-690,550/Placebo	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/97 (2.06%)	0/51 (0.00%)
Infections and infestations
Bronchopneumonia † 1	1/97 (1.03%)	0/51 (0.00%)
Injury, poisoning and procedural complications
Pelvic fracture † 1	1/97 (1.03%)	0/51 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 16.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	CP-690,550/Placebo	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	32/97 (32.99%)	26/51 (50.98%)
Blood and lymphatic system disorders
Anemia † 1	0/97 (0.00%)	1/51 (1.96%)
Lymph node pain † 1	0/97 (0.00%)	1/51 (1.96%)
Lymphopenia † 1	0/97 (0.00%)	1/51 (1.96%)
Thrombocytosis † 1	0/97 (0.00%)	1/51 (1.96%)
Ear and labyrinth disorders
Ear pain † 1	0/97 (0.00%)	1/51 (1.96%)
Gastrointestinal disorders
Abdominal pain upper † 1	3/97 (3.09%)	0/51 (0.00%)
Abdominal tenderness † 1	0/97 (0.00%)	1/51 (1.96%)
Diarrhoea † 1	1/97 (1.03%)	1/51 (1.96%)
Gastritis † 1	0/97 (0.00%)	1/51 (1.96%)
Gastrooesophageal reflux disease † 1	0/97 (0.00%)	3/51 (5.88%)
Nausea † 1	5/97 (5.15%)	2/51 (3.92%)
Vomiting † 1	2/97 (2.06%)	0/51 (0.00%)
General disorders
Medical device complication † 1	0/97 (0.00%)	1/51 (1.96%)
Infections and infestations
Gastroenteritis † 1	1/97 (1.03%)	1/51 (1.96%)
Nasopharyngitis † 1	8/97 (8.25%)	3/51 (5.88%)
Oral herpes † 1	2/97 (2.06%)	0/51 (0.00%)
Upper respiratory tract infection † 1	1/97 (1.03%)	1/51 (1.96%)
Urinary tract infection † 1	3/97 (3.09%)	2/51 (3.92%)
Injury, poisoning and procedural complications
Contusion † 1	0/97 (0.00%)	1/51 (1.96%)
Soft tissue injury † 1	0/97 (0.00%)	1/51 (1.96%)
Tooth fracture † 1	0/97 (0.00%)	1/51 (1.96%)
Investigations
Alanine aminotransferase increased † 1	2/97 (2.06%)	0/51 (0.00%)
Blood creatine phosphokinase increased † 1	2/97 (2.06%)	0/51 (0.00%)
Blood creatinine increased † 1	0/97 (0.00%)	1/51 (1.96%)
Blood pressure increased † 1	2/97 (2.06%)	0/51 (0.00%)
Blood urea increased † 1	0/97 (0.00%)	1/51 (1.96%)
Metabolism and nutrition disorders
Impaired fasting glucose † 1	1/97 (1.03%)	1/51 (1.96%)
Musculoskeletal and connective tissue disorders
Back pain † 1	2/97 (2.06%)	0/51 (0.00%)
Joint contracture † 1	0/97 (0.00%)	1/51 (1.96%)
Musculoskeletal chest pain † 1	0/97 (0.00%)	1/51 (1.96%)
Osteoarthritis † 1	2/97 (2.06%)	0/51 (0.00%)
Rheumatoid arthritis † 1	0/97 (0.00%)	1/51 (1.96%)
Nervous system disorders
Headache † 1	6/97 (6.19%)	1/51 (1.96%)
Somnolence † 1	0/97 (0.00%)	1/51 (1.96%)
Syncope † 1	0/97 (0.00%)	1/51 (1.96%)
Psychiatric disorders
Anxiety † 1	1/97 (1.03%)	1/51 (1.96%)
Insomnia † 1	0/97 (0.00%)	1/51 (1.96%)
Reproductive system and breast disorders
Menorrhagia † 1	0/97 (0.00%)	1/51 (1.96%)
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal † 1	0/97 (0.00%)	1/51 (1.96%)
Skin and subcutaneous tissue disorders
Urticaria † 1	0/97 (0.00%)	1/51 (1.96%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 16.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Kremer JM, Kivitz AJ, Simon-Campos JA, Nasonov EL, Tony HP, Lee SK, Vlahos B, Hammond C, Bukowski J, Li H, Schulman SL, Raber S, Zuckerman A, Isaacs JD. Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial. Arthritis Res Ther. 2015 Apr 6;17(1):95. doi: 10.1186/s13075-015-0612-7.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01484561
• Other Study ID Numbers: A3921152
• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Results First Submitted: January 11, 2014
• Results First Posted: April 2, 2014
• Last Update Posted: April 2, 2014