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Trial record 1 of 1 for:    NCT01786668
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Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01786668
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
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
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
Hide 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
Arm/Group Title Tofacitinib 2 mg BID Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo BID Total
Hide 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
Hide 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
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%
1.Primary Outcome
Title Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 2 mg BID Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo BID
Hide 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
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 15.69
Week 4 (n=15, 12, 15, 11) 28.85 23.08 28.85 21.57
Week 8 (n=18, 17, 21, 14) 34.62 32.69 40.38 27.45
Week 12 (n=24, 22, 22, 12) 46.15 42.31 42.31 23.53
Hide 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 0.539
Comments [Not Specified]
Method Normal approximation for two proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.15
Confidence Interval (2-Sided) 95%
-17.38 to 9.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.75
Estimation Comments [Not Specified]
Hide 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 0.473
Comments [Not Specified]
Method Normal approximation for two proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)