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A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

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: NCT01458574
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Placebo
Drug: CP690,550
Drug: CP-690,550
Enrollment 593
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Period Title: Overall Study
Started 198 197 198
Treated 198 196 198
Completed 111 126 53
Not Completed 87 71 145
Reason Not Completed
Adverse Event             5             9             7
Lack of Efficacy             70             53             132
Lost to Follow-up             3             2             1
Pregnancy             1             1             0
Protocol Violation             0             1             0
Withdrawal by Subject             6             3             5
Other             2             1             0
Randomized but not treated             0             1             0
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo Total
Hide Arm/Group Description Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Total of all reporting groups
Overall Number of Baseline Participants 198 197 198 593
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 197 participants 198 participants 593 participants
41.9  (13.7) 42.9  (14.4) 43.4  (14) 42.7  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 197 participants 198 participants 593 participants
Female
95
  48.0%
87
  44.2%
82
  41.4%
264
  44.5%
Male
103
  52.0%
110
  55.8%
116
  58.6%
329
  55.5%
1.Primary Outcome
Title Percentage of Participants In Remission at Week 52
Hide Description Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
34.3 40.6 11.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
15.3 to 31.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 29.5
Confidence Interval (2-Sided) 95%
21.4 to 37.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at Week 52
Hide Description Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
37.4 45.7 13.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.2
Confidence Interval (2-Sided) 95%
16.0 to 32.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 32.6
Confidence Interval (2-Sided) 95%
24.2 to 41.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Hide Description Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 65 55 59
Measure Type: Number
Unit of Measure: percentage of participants
35.4 47.3 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.3
Confidence Interval (2-Sided) 95%
17.4 to 43.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 42.2
Confidence Interval (2-Sided) 95%
27.9 to 56.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants in Remission at Week 24
Hide Description Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
33.8 35.5 11.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
14.8 to 30.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.4
Confidence Interval (2-Sided) 95%
16.4 to 32.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants in Sustained Remission
Hide Description Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
22.2 25.4 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
10.6 to 23.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.3
Confidence Interval (2-Sided) 95%
13.5 to 27.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at Week 24
Hide Description Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
43.9 46.2 17.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 26.8
Confidence Interval (2-Sided) 95%
18.1 to 35.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 29.0
Confidence Interval (2-Sided) 95%
20.3 to 37.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Sustained Mucosal Healing
Hide Description Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
27.8 33.0 6.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
14.1 to 28.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 26.4
Confidence Interval (2-Sided) 95%
19.0 to 33.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Hide Description Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 105 89 101
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 52.4 66.3 21.8
Week 52 41.9 55.1 11.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.6
Confidence Interval (2-Sided) 95%
18.1 to 43.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 44.5
Confidence Interval (2-Sided) 95%
31.8 to 57.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.0
Confidence Interval (2-Sided) 95%
18.7 to 41.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 43.2
Confidence Interval (2-Sided) 95%
31.1 to 55.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Hide Description Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 105 89 101
Measure Type: Number
Unit of Measure: percentage of participants
33.3 49.4 8.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.4
Confidence Interval (2-Sided) 95%
13.8 to 35.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.5
Confidence Interval (2-Sided) 95%
28.7 to 52.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Clinical Response at Week 24 and 52
Hide Description Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 63.6 70.6 33.3
Week 52 51.5 61.9 20.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.3
Confidence Interval (2-Sided) 95%
20.9 to 39.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 37.2
Confidence Interval (2-Sided) 95%
28.1 to 46.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.3
Confidence Interval (2-Sided) 95%
22.4 to 40.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 41.7
Confidence Interval (2-Sided) 95%
32.9 to 50.5
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Sustained Clinical Response
Hide Description Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
49.0 59.4 19.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 29.8
Confidence Interval (2-Sided) 95%
20.9 to 38.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.2
Confidence Interval (2-Sided) 95%
31.4 to 49.0
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants in Clinical Remission at Week 24 and 52
Hide Description Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 34.3 35.5 11.1
Week 52 34.3 41.1 11.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
15.3 to 31.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.4
Confidence Interval (2-Sided) 95%
16.4 to 32.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
15.3 to 31.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.0
Confidence Interval (2-Sided) 95%
21.9 to 38.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants in Sustained Clinical Remission
Hide Description Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
22.2 25.9 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
10.6 to 23.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.8
Confidence Interval (2-Sided) 95%
14.0 to 27.7
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants in Deep Remission at Week 24 and 52
Hide Description Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 14.1 10.7 4.0
Week 52 14.6 15.2 4.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.1
Confidence Interval (2-Sided) 95%
4.5 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.6
Confidence Interval (2-Sided) 95%
1.5 to 11.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
5.0 to 16.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
5.5 to 16.9
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants in Sustained Deep Remission
Hide Description Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
6.1 3.6 0.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.1 to 9.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0350
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.3 to 5.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants in Symptomatic Remission at Week 24 and 52
Hide Description Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 23.7 21.8 6.6
Week 52 22.7 26.9 7.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
10.3 to 24.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 15.3
Confidence Interval (2-Sided) 95%
8.5 to 22.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
8.8 to 22.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
12.7 to 27.0
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants in Sustained Symptomatic Remission
Hide Description Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
13.6 15.7 2.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
5.9 to 16.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
7.7 to 18.7
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants in Endoscopic Remission at Week 24 and 52
Hide Description Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 16.2 12.2 4.0
Week 52 14.6 16.8 4.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
6.3 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
2.8 to 13.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
5.0 to 16.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
6.8 to 18.6
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants in Sustained Endoscopic Remission
Hide Description Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Measure Type: Number
Unit of Measure: percentage of participants
6.1 5.1 0.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.1 to 9.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
1.4 to 7.8
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Total Mayo Score at Baseline, Week 24 and 52
Hide Description Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n = 198, 197, 198) 3.3  (1.8) 3.4  (1.8) 3.3  (1.8)
Week 24 (n = 179, 186, 181) 4.1  (3.4) 4.0  (3.3) 6.7  (3.5)
Week 52 (n = 129, 137, 68) 3.2  (3.1) 2.6  (2.7) 4.6  (3.2)
21.Secondary Outcome
Title Change From Baseline in Total Mayo Score at Week 24 and 52
Hide Description Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 198 197 198
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 24 (n = 179, 186, 181) 0.3  (0.3) 0.0  (0.3) 2.9  (0.3)
Change at Week 52 (n = 129, 137, 68) 0.4  (0.3) -0.4  (0.3) 2.9  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-3.2 to -1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-3.5 to -2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-3.4 to -1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-4.1 to -2.5
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants in Remission, Among Participants With Remission at Baseline
Hide Description Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 65 55 59
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 55.4 63.6 15.3
Week 52 46.2 56.4 10.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.1
Confidence Interval (2-Sided) 95%
25.0 to 55.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 48.4
Confidence Interval (2-Sided) 95%
32.7 to 64.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 36.0
Confidence Interval (2-Sided) 95%
21.6 to 50.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 46.2
Confidence Interval (2-Sided) 95%
31.0 to 61.4
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Hide Description Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 65 55 59
Measure Type: Number
Unit of Measure: percentage of participants
36.9 47.3 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.8
Confidence Interval (2-Sided) 95%
18.8 to 44.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 42.2
Confidence Interval (2-Sided) 95%
27.9 to 56.5
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Hide Description Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 65 55 59
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 53.8 63.6 15.3
Week 52 44.6 56.4 10.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 38.6
Confidence Interval (2-Sided) 95%
23.4 to 53.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 48.4
Confidence Interval (2-Sided) 95%
32.7 to 64.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 34.4
Confidence Interval (2-Sided) 95%
20.1 to 48.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 46.2
Confidence Interval (2-Sided) 95%
31.0 to 61.4
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Hide Description Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 101 87 101
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 23.8 24.1 10.9
Week 52 27.7 27.6 10.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.9
Confidence Interval (2-Sided) 95%
2.6 to 23.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
2.4 to 24.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 16.8
Confidence Interval (2-Sided) 95%
6.2 to 27.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
5.5 to 27.9
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Hide Description Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description:
Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
Overall Number of Participants Analyzed 101 87 101
Measure Type: Number
Unit of Measure: percentage of participants
12.9 16.1 5.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 5 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0419
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
0.1 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo
Comments P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0121
Comments [Not Specified]
Method CMH chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
2.3 to 19.9
Estimation Comments [Not Specified]
Time Frame Baseline up to Week 57
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis included all treated participants.
 
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Hide Arm/Group Description Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
All-Cause Mortality
Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/198 (5.05%)   11/196 (5.61%)   13/198 (6.57%) 
Cardiac disorders       
Myocardial infarction * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Colitis ulcerative * 1  2/198 (1.01%)  1/196 (0.51%)  8/198 (4.04%) 
Diarrhoea * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Gastrointestinal haemorrhage * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Pancreatitis * 1  0/198 (0.00%)  0/196 (0.00%)  1/198 (0.51%) 
General disorders       
Chest pain * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Malaise * 1  0/198 (0.00%)  0/196 (0.00%)  1/198 (0.51%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Infections and infestations       
Bacterial diarrhoea * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Diverticulitis * 1  0/198 (0.00%)  0/196 (0.00%)  1/198 (0.51%) 
Peritonsillar abscess * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Subcutaneous abscess * 1  0/198 (0.00%)  0/196 (0.00%)  1/198 (0.51%) 
Urinary tract infection * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Injury, poisoning and procedural complications       
Lower limb fracture * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Lumbar vertebral fracture * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Spinal compression fracture * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Spondylolisthesis * 1  1/198 (0.51%)  0/196 (0.00%)  0/198 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bowen's disease * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Invasive ductal breast carcinoma * 1 [1]  0/95 (0.00%)  0/86 (0.00%)  1/82 (1.22%) 
Squamous cell carcinoma of skin * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Nervous system disorders       
Generalised tonic-clonic seizure * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Haemorrhagic stroke * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Sciatica * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Seizure * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1 [1]  1/95 (1.05%)  0/86 (0.00%)  0/82 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis acneiform * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Rash maculo-papular * 1  0/198 (0.00%)  1/196 (0.51%)  0/198 (0.00%) 
Vascular disorders       
Embolism venous * 1  0/198 (0.00%)  0/196 (0.00%)  1/198 (0.51%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
[1]
This AE was gender specific.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   87/198 (43.94%)   107/196 (54.59%)   108/198 (54.55%) 
Gastrointestinal disorders       
Abdominal pain * 1  5/198 (2.53%)  7/196 (3.57%)  11/198 (5.56%) 
Colitis ulcerative * 1  35/198 (17.68%)  29/196 (14.80%)  64/198 (32.32%) 
General disorders       
Fatigue * 1  8/198 (4.04%)  4/196 (2.04%)  11/198 (5.56%) 
Infections and infestations       
Herpes zoster * 1  2/198 (1.01%)  10/196 (5.10%)  1/198 (0.51%) 
Nasopharyngitis * 1  19/198 (9.60%)  27/196 (13.78%)  11/198 (5.56%) 
Upper respiratory tract infection * 1  13/198 (6.57%)  12/196 (6.12%)  7/198 (3.54%) 
Investigations       
Blood creatine phosphokinase increased * 1  6/198 (3.03%)  13/196 (6.63%)  4/198 (2.02%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia * 1  4/198 (2.02%)  11/196 (5.61%)  2/198 (1.01%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  17/198 (8.59%)  17/196 (8.67%)  19/198 (9.60%) 
Nervous system disorders       
Headache * 1  17/198 (8.59%)  6/196 (3.06%)  12/198 (6.06%) 
Skin and subcutaneous tissue disorders       
Rash * 1  6/198 (3.03%)  11/196 (5.61%)  8/198 (4.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458574    
Other Study ID Numbers: A3921096
2011-004580-79 ( EudraCT Number )
OCTAVESUSTAIN ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2011
First Posted: October 25, 2011
Results First Submitted: April 7, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017