Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT01786668

Recruitment Status : Completed

First Posted : February 8, 2013

Results First Posted : June 10, 2016

Last Update Posted : June 10, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Ankylosing Spondylitis
Interventions	Drug: Tofacitinib 2 mg Drug: Tofacitinib 5 mg Drug: Tofacitinib 10 mg Drug: Placebo
Enrollment	208

Participant Flow

Recruitment Details
Pre-assignment Details	In total 208 participants were randomized to double-blind treatment; 52 to each treatment group (tofacitinib 2 milligrams [mg] twice daily [BID], tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo BID). One participant was randomized to the placebo group but did not receive study drug, as such only 207 participants received study treatment.


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Period Title: Overall Study
Started	52	52	52	51
Completed	51	51	47	47
Not Completed	1	1	5	4
Reason Not Completed
Adverse Event	0	1	1	2
Withdrawal by Subject	0	0	3	1
Pregnancy	0	0	0	1
Lost to Follow-up	1	0	1	0

Baseline Characteristics

Arm/Group Title		Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID	Total
Arm/Group Description		Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Total of all reporting groups
Arm/Group Description		Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		52	52	52	51	207
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Safety population - included participants who received at least 1 dose of study medication
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
Age	Number Analyzed	52 participants	52 participants	52 participants	51 participants	207 participants
Age		41.8 (12.3)	41.2 (10.3)	41.6 (12.2)	41.9 (12.9)	41.6 (11.9)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	52 participants	52 participants	52 participants	51 participants	207 participants
	Female	18 34.6%	13 25.0%	14 26.9%	19 37.3%	64 30.9%
	Male	34 65.4%	39 75.0%	38 73.1%	32 62.7%	143 69.1%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
Description	The primary analysis of this outcome measure was performed using the E...
Description	The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
	56.0	63.0	67.4	40.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Emax model - 95% Confidence Interval represents 95% Credible Interval
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Emax Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	15.8
	Confidence Interval	(2-Sided) 95% 5.0 to 30.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Emax model - 95% Confidence Interval represents 95% Credible Interval
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Emax Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.9
	Confidence Interval	(2-Sided) 95% 8.4 to 37.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Emax model - 95% Confidence Interval represents 95% Credible Interval
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Emax Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	27.3
	Confidence Interval	(2-Sided) 95% 10.7 to 43.4
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Percentage of Participants Achieving ASAS20 at Week 12
Description	The supportive analysis of this outcome measure was performed using th...
Description	The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
	51.92	80.77	55.77	41.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.271
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	10.75
	Confidence Interval	(2-Sided) 95% -8.41 to 29.90
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.77
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	39.59
	Confidence Interval	(2-Sided) 95% 22.35 to 56.83
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.80
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.134
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.59
	Confidence Interval	(2-Sided) 95% -4.50 to 33.69
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.74
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
Description	Clinical response to treatment was assessed according to ASAS20 criter...
Description	Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Time Frame	Baseline, Week 2, Week 4, Week 8

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit.


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=21,17,18,14)	40.38	32.69	34.62	27.45
Week 4 (n=25,29,25,17)	48.08	55.77	48.08	33.33
Week 8 (n=30, 37, 28, 22)	57.69	71.15	53.85	43.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.162
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	12.93
	Confidence Interval	(2-Sided) 95% -5.17 to 31.04
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.24
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.561
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.24
	Confidence Interval	(2-Sided) 95% -12.44 to 22.92
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.02
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.430
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.16
	Confidence Interval	(2-Sided) 95% -10.65 to 24.97
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.09
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.123
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.74
	Confidence Interval	(2-Sided) 95% -4.01 to 33.50
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.57
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.019
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.44
	Confidence Interval	(2-Sided) 95% 3.74 to 41.13
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.54
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.123
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.74
	Confidence Interval	(2-Sided) 95% -4.01 to 33.50
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.57
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.135
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.56
	Confidence Interval	(2-Sided) 95% -4.55 to 33.66
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.75
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	28.02
	Confidence Interval	(2-Sided) 95% 9.68 to 46.36
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.36
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.274
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	10.71
	Confidence Interval	(2-Sided) 95% -8.48 to 29.90
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.79
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12
Description	SPARCC scoring consists of assessing six SI joint MRI image coronal sl...
Description	SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	42	44	44	34
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
	-1.70 (0.779)	-3.15 (0.788)	-3.55 (0.795)	-0.81 (0.806)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.427
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95% -3.11 to 1.32
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.123
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.039
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.35
	Confidence Interval	(2-Sided) 95% -4.58 to -0.12
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.130
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.016
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.74
	Confidence Interval	(2-Sided) 95% -4.97 to -0.51
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.131
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12
Description	SPARCC scoring of the magnetic resonance imaging (MRI) of the spine co...
Description	SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	41	44	44	34
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
	-3.09 (1.061)	-5.51 (1.063)	-6.57 (1.073)	-0.09 (1.085)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.050
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.00
	Confidence Interval	(2-Sided) 95% -5.99 to -0.00
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.517
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.42
	Confidence Interval	(2-Sided) 95% -8.42 to -2.42
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.520
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.47
	Confidence Interval	(2-Sided) 95% -9.48 to -3.46
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.525
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12
Description	Berlin modification of the ASspiMRI is a measure of acute lesion as de...
Description	Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	41	44	44	34
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
	-1.05 (0.364)	-2.22 (0.364)	-2.13 (0.368)	-0.41 (0.372)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.221
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95% -1.66 to 0.39
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.520
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.80
	Confidence Interval	(2-Sided) 95% -2.83 to -0.78
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.520
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.71
	Confidence Interval	(2-Sided) 95% -2.75 to -0.68
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.523
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
Description	ASAS 40 is defined as ≥40% and absolute change of ≥2 units...
Description	ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit.


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=7, 7, 9, 8)	13.46	13.46	17.31	15.69
Week 4 (n=15, 17, 11, 8)	28.85	32.69	21.15	15.69
Week 8 (n=15, 18, 19, 14)	28.85	34.62	36.54	27.45
Week 12 (n=22, 24, 20, 10)	42.31	46.15	38.46	19.61

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.749
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.22
	Confidence Interval	(2-Sided) 95% -15.85 to 11.40
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.95
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.749
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.22
	Confidence Interval	(2-Sided) 95% -15.85 to 11.40
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.95
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.824
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 95% -12.71 to 15.95
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.31
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.104
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	13.16
	Confidence Interval	(2-Sided) 95% -2.69 to 29.01
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.09
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.040
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	17.01
	Confidence Interval	(2-Sided) 95% 0.81 to 33.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.26
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.473
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.47
	Confidence Interval	(2-Sided) 95% -9.46 to 20.40
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.62
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.875
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95% -15.97 to 18.76
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.86
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.430
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.16
	Confidence Interval	(2-Sided) 95% -10.65 to 24.97
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.09
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.320
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	9.09
	Confidence Interval	(2-Sided) 95% -8.84 to 27.01
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.15
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.010
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.70
	Confidence Interval	(2-Sided) 95% 5.41 to 39.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.82
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	26.55
	Confidence Interval	(2-Sided) 95% 9.16 to 43.93
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.87
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.031
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	18.85
	Confidence Interval	(2-Sided) 95% 1.72 to 35.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.74
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
Description	ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global ...
Description	ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=12, 7, 11, 4)	23.08	13.46	21.15	7.84
Week 4 (n=10, 16, 15, 4)	19.23	30.77	28.85	7.84
Week 8 (n=11, 22, 15, 5)	21.15	42.31	28.85	9.80
Week 12 (n=10, 26, 20, 8)	19.23	50.00	38.46	15.69

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.028
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	15.23
	Confidence Interval	(2-Sided) 95% 1.61 to 28.86
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.95
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.353
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.62
	Confidence Interval	(2-Sided) 95% -6.23 to 17.47
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.05
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.050
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	13.31
	Confidence Interval	(2-Sided) 95% -0.02 to 26.64
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.80
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.086
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	11.39
	Confidence Interval	(2-Sided) 95% -1.62 to 24.39
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.93
	Confidence Interval	(2-Sided) 95% 8.37 to 37.48
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.43
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	21.00
	Confidence Interval	(2-Sided) 95% 6.65 to 35.36
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.32
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.106
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	11.35
	Confidence Interval	(2-Sided) 95% -2.43 to 25.13
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.03
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	32.50
	Confidence Interval	(2-Sided) 95% 16.79 to 48.22
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.02
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.012
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	19.04
	Confidence Interval	(2-Sided) 95% 4.27 to 33.81
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.54
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.635
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.54
	Confidence Interval	(2-Sided) 95% -11.10 to 18.19
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.47
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	34.31
	Confidence Interval	(2-Sided) 95% 17.45 to 51.18
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.60
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.007
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.78
	Confidence Interval	(2-Sided) 95% 6.21 to 39.34
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.45
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
Description	The ASDAS(CRP) is a derived score that uses back pain, duration of mor...
Description	The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	51	51	51	50
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
Week 2	-0.68 (0.096)	-1.00 (0.096)	-0.97 (0.096)	-0.50 (0.097)
Week 4	-1.01 (0.099)	-1.20 (0.099)	-1.17 (0.099)	-0.58 (0.100)
Week 8	-1.08 (0.111)	-1.36 (0.111)	-1.32 (0.112)	-0.73 (0.112)
Week 12	-1.23 (0.119)	-1.41 (0.119)	-1.37 (0.121)	-0.68 (0.123)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.175
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95% -0.46 to 0.08
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.136
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95% -0.77 to -0.24
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.136
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95% -0.74 to -0.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.136
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95% -0.70 to -0.15
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.141
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95% -0.90 to -0.34
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.141
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95% -0.86 to -0.31
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.141
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.026
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95% -0.66 to -0.04
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.158
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95% -0.94 to -0.32
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.157
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95% -0.90 to -0.27
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.159
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95% -0.89 to -0.21
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.171
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95% -1.07 to -0.39
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.171
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95% -1.03 to -0.35
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.172
	Estimation Comments	[Not Specified]

10.Secondary Outcome


Title	Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
Description	The ASDAS clinically important improvement was calculated from the ASD...
Description	The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=14, 25, 21, 8)	26.92	48.08	40.38	15.69
Week4 (n=22, 30, 27, 10)	42.31	57.69	51.92	19.61
Week 8 (n=23, 31, 31, 15)	44.23	59.62	59.62	29.41
Week 12 (n=27, 33, 29, 14)	51.92	63.46	55.77	27.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.159
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	11.24
	Confidence Interval	(2-Sided) 95% -4.41 to 26.89
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.99
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	32.39
	Confidence Interval	(2-Sided) 95% 15.54 to 49.24
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.60
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	24.70
	Confidence Interval	(2-Sided) 95% 8.04 to 41.36
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.50
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.010
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.70
	Confidence Interval	(2-Sided) 95% 5.41 to 39.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.82
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	38.08
	Confidence Interval	(2-Sided) 95% 20.79 to 55.38
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.82
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	32.32
	Confidence Interval	(2-Sided) 95% 14.90 to 49.73
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.88
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.114
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.82
	Confidence Interval	(2-Sided) 95% -3.58 to 33.22
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.39
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	30.20
	Confidence Interval	(2-Sided) 95% 11.92 to 48.49
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.33
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	30.20
	Confidence Interval	(2-Sided) 95% 11.92 to 48.49
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.33
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	24.47
	Confidence Interval	(2-Sided) 95% 6.18 to 42.76
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.33
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	36.01
	Confidence Interval	(2-Sided) 95% 18.09 to 53.94
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.15
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	28.32
	Confidence Interval	(2-Sided) 95% 10.09 to 46.55
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.30
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
Description	The ASDAS major improvement was calculated from the ASDAS data. The AS...
Description	The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=4, 4, 4, 1)	7.69	7.69	7.69	1.96
Week 4 (n=6, 6, 8, 3)	11.54	11.54	15.38	5.88
Week 8 (n=6, 14, 12, 5)	11.54	26.92	23.08	9.80
Week 12 (n=10, 12, 13, 6)	19.23	23.08	25.00	11.76

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.170
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.73
	Confidence Interval	(2-Sided) 95% -2.45 to 13.91
	Parameter Dispersion	Type: Standard Error of the mean Value: 4.17
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.170
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.73
	Confidence Interval	(2-Sided) 95% -2.45 to 13.91
	Parameter Dispersion	Type: Standard Error of the mean Value: 4.17
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.170
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.73
	Confidence Interval	(2-Sided) 95% -2.45 to 13.91
	Parameter Dispersion	Type: Standard Error of the mean Value: 4.17
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.306
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.66
	Confidence Interval	(2-Sided) 95% -5.17 to 16.48
	Parameter Dispersion	Type: Standard Error of the mean Value: 5.52
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.306
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.66
	Confidence Interval	(2-Sided) 95% -5.17 to 16.48
	Parameter Dispersion	Type: Standard Error of the mean Value: 5.52
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.113
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	9.50
	Confidence Interval	(2-Sided) 95% -2.24 to 21.24
	Parameter Dispersion	Type: Standard Error of the mean Value: 5.99
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.775
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.73
	Confidence Interval	(2-Sided) 95% -10.18 to 13.65
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.08
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.021
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	17.12
	Confidence Interval	(2-Sided) 95% 2.56 to 31.68
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.43
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.064
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	13.27
	Confidence Interval	(2-Sided) 95% -0.79 to 27.34
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.17
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.292
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.47
	Confidence Interval	(2-Sided) 95% -6.42 to 21.36
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.09
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.125
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	11.31
	Confidence Interval	(2-Sided) 95% -3.16 to 25.78
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.38
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.078
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	13.24
	Confidence Interval	(2-Sided) 95% -1.49 to 27.96
	Parameter Dispersion	Type: Standard Error of the mean Value: 7.51
	Estimation Comments	[Not Specified]

12.Secondary Outcome


Title	Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
Description	The ASDAS inactive disease was calculated from the ASDAS data. The ASD...
Description	The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=1, 1, 1, 0)	1.92	1.92	1.92	0.00
Week 4 (n=1, 3, 4, 1)	1.92	5.77	7.69	1.96
Week 8 (n=3, 1, 5, 1)	5.77	1.92	9.62	1.96
Week 12 (n=7, 7, 8, 4)	13.46	13.46	15.38	7.84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.313
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95% -1.81 to 5.66
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.90
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.313
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95% -1.81 to 5.66
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.90
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.313
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95% -1.81 to 5.66
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.90
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.989
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95% -5.37 to 5.29
	Parameter Dispersion	Type: Standard Error of the mean Value: 2.72
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.313
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.81
	Confidence Interval	(2-Sided) 95% -3.58 to 11.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 3.77
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.170
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.73
	Confidence Interval	(2-Sided) 95% -2.45 to 13.91
	Parameter Dispersion	Type: Standard Error of the mean Value: 4.17
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.313
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.81
	Confidence Interval	(2-Sided) 95% -3.58 to 11.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 3.77
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.989
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95% -5.37 to 5.29
	Parameter Dispersion	Type: Standard Error of the mean Value: 2.72
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.091
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.65
	Confidence Interval	(2-Sided) 95% -1.22 to 16.52
	Parameter Dispersion	Type: Standard Error of the mean Value: 4.53
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.353
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.62
	Confidence Interval	(2-Sided) 95% -6.23 to 17.47
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.05
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.353
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.62
	Confidence Interval	(2-Sided) 95% -6.23 to 17.47
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.05
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.228
	Comments	[Not Specified]
	Method	Normal approximation for two proportions
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.54
	Confidence Interval	(2-Sided) 95% -4.73 to 19.81
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.26
	Estimation Comments	[Not Specified]

13.Secondary Outcome


Title	Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
Description	BASDAI is a validated self-assessment tool used to determine disease a...
Description	BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	51	52	51	51
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
Week 2	-1.45 (0.219)	-1.53 (0.217)	-1.24 (0.219)	-1.42 (0.219)
Week 4	-1.90 (0.242)	-1.93 (0.240)	-1.84 (0.242)	-1.60 (0.243)
Week 8	-2.16 (0.268)	-2.39 (0.267)	-2.35 (0.271)	-1.87 (0.271)
Week 12	-2.75 (0.277)	-2.88 (0.276)	-2.68 (0.281)	-1.85 (0.283)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.926
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95% -0.64 to 0.58
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.310
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.718
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95% -0.72 to 0.50
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.308
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.570
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95% -0.43 to 0.79
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.310
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.384
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95% -0.97 to 0.38
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.343
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.334
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95% -1.00 to 0.34
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.341
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.474
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95% -0.92 to 0.43
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.343
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.445
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95% -1.04 to 0.46
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.381
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.174
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95% -1.27 to 0.23
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.380
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.217
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95% -1.23 to 0.28
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.383
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 2 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.024
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.90
	Confidence Interval	(2-Sided) 95% -1.69 to -0.12
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.396
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 5 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.010
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.03
	Confidence Interval	(2-Sided) 95% -1.81 to -0.24
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.396
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.038
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.83
	Confidence Interval	(2-Sided) 95% -1.62 to -0.04
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.399
	Estimation Comments	[Not Specified]

14.Secondary Outcome


Title	Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
Description	BASDAI is a validated self-assessment tool used to determine disease a...
Description	BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.
Time Frame	Baseline, Week 2, Week 4, Week 8, Week 12

Outcome Measure Data

Analysis Population Description

FAS - n=number of responders at each visit


Arm/Group Title	Tofacitinib 2 mg BID	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description:	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...	Participants were administered 4 ta...
Arm/Group Description:	Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.	Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
Overall Number of Participants Analyzed	52	52	52	51
Measure Type: Number Unit of Measure: Percentage of participants
Week 2 (n=6, 11, 7, 8)	11.54	21.15	13.46