Trial Outcomes & Findings for A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (NCT NCT01458574)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

593 participants

Primary outcome timeframe

Week 52

Results posted on

2017-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Tofacitinib 5 mg BID 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.	Tofacitinib 10 mg BID 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.	Placebo 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 Study STARTED	198	197	198
Overall Study Treated	198	196	198
Overall Study COMPLETED	111	126	53
Overall Study NOT COMPLETED	87	71	145

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib 5 mg BID 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.	Tofacitinib 10 mg BID 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.	Placebo 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 Study Adverse Event	5	9	7
Overall Study Lack of Efficacy	70	53	132
Overall Study Lost to Follow-up	3	2	1
Overall Study Pregnancy	1	1	0
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	6	3	5
Overall Study Other	2	1	0
Overall Study Randomized but not treated	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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 n=593 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 13.7 • n=5 Participants	42.9 years STANDARD_DEVIATION 14.4 • n=7 Participants	43.4 years STANDARD_DEVIATION 14 • n=5 Participants	42.7 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	87 Participants n=7 Participants	82 Participants n=5 Participants	264 Participants n=4 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	110 Participants n=7 Participants	116 Participants n=5 Participants	329 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants In Remission at Week 52	34.3 percentage of participants	40.6 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants With Mucosal Healing at Week 52	37.4 percentage of participants	45.7 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=65 Participants 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.	Tofacitinib 10 mg BID n=55 Participants 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.	Placebo n=59 Participants 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.
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	35.4 percentage of participants	47.3 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Remission at Week 24	33.8 percentage of participants	35.5 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Sustained Remission	22.2 percentage of participants	25.4 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants With Mucosal Healing at Week 24	43.9 percentage of participants	46.2 percentage of participants	17.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants With Sustained Mucosal Healing	27.8 percentage of participants	33.0 percentage of participants	6.6 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=105 Participants 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.	Tofacitinib 10 mg BID n=89 Participants 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.	Placebo n=101 Participants 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.
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline Week 24	52.4 percentage of participants	66.3 percentage of participants	21.8 percentage of participants
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline Week 52	41.9 percentage of participants	55.1 percentage of participants	11.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=105 Participants 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.	Tofacitinib 10 mg BID n=89 Participants 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.	Placebo n=101 Participants 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.
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline	33.3 percentage of participants	49.4 percentage of participants	8.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants With Clinical Response at Week 24 and 52 Week 24	63.6 percentage of participants	70.6 percentage of participants	33.3 percentage of participants
Percentage of Participants With Clinical Response at Week 24 and 52 Week 52	51.5 percentage of participants	61.9 percentage of participants	20.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants With Sustained Clinical Response	49.0 percentage of participants	59.4 percentage of participants	19.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Clinical Remission at Week 24 and 52 Week 24	34.3 percentage of participants	35.5 percentage of participants	11.1 percentage of participants
Percentage of Participants in Clinical Remission at Week 24 and 52 Week 52	34.3 percentage of participants	41.1 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Sustained Clinical Remission	22.2 percentage of participants	25.9 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Deep Remission at Week 24 and 52 Week 24	14.1 percentage of participants	10.7 percentage of participants	4.0 percentage of participants
Percentage of Participants in Deep Remission at Week 24 and 52 Week 52	14.6 percentage of participants	15.2 percentage of participants	4.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Sustained Deep Remission	6.1 percentage of participants	3.6 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Symptomatic Remission at Week 24 and 52 Week 24	23.7 percentage of participants	21.8 percentage of participants	6.6 percentage of participants
Percentage of Participants in Symptomatic Remission at Week 24 and 52 Week 52	22.7 percentage of participants	26.9 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Sustained Symptomatic Remission	13.6 percentage of participants	15.7 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Endoscopic Remission at Week 24 and 52 Week 24	16.2 percentage of participants	12.2 percentage of participants	4.0 percentage of participants
Percentage of Participants in Endoscopic Remission at Week 24 and 52 Week 52	14.6 percentage of participants	16.8 percentage of participants	4.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Percentage of Participants in Sustained Endoscopic Remission	6.1 percentage of participants	5.1 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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 Mayo Score at Baseline, Week 24 and 52 Baseline (n = 198, 197, 198)	3.3 units on a scale Standard Deviation 1.8	3.4 units on a scale Standard Deviation 1.8	3.3 units on a scale Standard Deviation 1.8
Total Mayo Score at Baseline, Week 24 and 52 Week 24 (n = 179, 186, 181)	4.1 units on a scale Standard Deviation 3.4	4.0 units on a scale Standard Deviation 3.3	6.7 units on a scale Standard Deviation 3.5
Total Mayo Score at Baseline, Week 24 and 52 Week 52 (n = 129, 137, 68)	3.2 units on a scale Standard Deviation 3.1	2.6 units on a scale Standard Deviation 2.7	4.6 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=198 Participants 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.	Tofacitinib 10 mg BID n=197 Participants 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.	Placebo n=198 Participants 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.
Change From Baseline in Total Mayo Score at Week 24 and 52 Change at Week 24 (n = 179, 186, 181)	0.3 units on a scale Standard Error 0.3	0.0 units on a scale Standard Error 0.3	2.9 units on a scale Standard Error 0.3
Change From Baseline in Total Mayo Score at Week 24 and 52 Change at Week 52 (n = 129, 137, 68)	0.4 units on a scale Standard Error 0.3	-0.4 units on a scale Standard Error 0.3	2.9 units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=65 Participants 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.	Tofacitinib 10 mg BID n=55 Participants 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.	Placebo n=59 Participants 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.
Percentage of Participants in Remission, Among Participants With Remission at Baseline Week 24	55.4 percentage of participants	63.6 percentage of participants	15.3 percentage of participants
Percentage of Participants in Remission, Among Participants With Remission at Baseline Week 52	46.2 percentage of participants	56.4 percentage of participants	10.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=65 Participants 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.	Tofacitinib 10 mg BID n=55 Participants 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.	Placebo n=59 Participants 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.
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline	36.9 percentage of participants	47.3 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=65 Participants 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.	Tofacitinib 10 mg BID n=55 Participants 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.	Placebo n=59 Participants 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.
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline Week 52	44.6 percentage of participants	56.4 percentage of participants	10.2 percentage of participants
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline Week 24	53.8 percentage of participants	63.6 percentage of participants	15.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=101 Participants 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.	Tofacitinib 10 mg BID n=87 Participants 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.	Placebo n=101 Participants 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.
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline Week 24	23.8 percentage of participants	24.1 percentage of participants	10.9 percentage of participants
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline Week 52	27.7 percentage of participants	27.6 percentage of participants	10.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24, 52

Population: FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 5 mg BID n=101 Participants 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.	Tofacitinib 10 mg BID n=87 Participants 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.	Placebo n=101 Participants 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.
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline	12.9 percentage of participants	16.1 percentage of participants	5.0 percentage of participants

Adverse Events

Tofacitinib 5 mg BID

Serious events: 10 serious events

Other events: 87 other events

Deaths: 0 deaths

Tofacitinib 10 mg BID

Serious events: 11 serious events

Other events: 107 other events

Deaths: 0 deaths

Placebo

Serious events: 13 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tofacitinib 5 mg BID n=198 participants at risk 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.	Tofacitinib 10 mg BID n=196 participants at risk 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.	Placebo n=198 participants at risk 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.
Gastrointestinal disorders Abdominal pain	2.5% 5/198 • Baseline up to Week 57 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.	3.6% 7/196 • Baseline up to Week 57 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.	5.6% 11/198 • Baseline up to Week 57 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.
Gastrointestinal disorders Colitis ulcerative	17.7% 35/198 • Baseline up to Week 57 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.	14.8% 29/196 • Baseline up to Week 57 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.	32.3% 64/198 • Baseline up to Week 57 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.
General disorders Fatigue	4.0% 8/198 • Baseline up to Week 57 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.	2.0% 4/196 • Baseline up to Week 57 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.	5.6% 11/198 • Baseline up to Week 57 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.
Infections and infestations Herpes zoster	1.0% 2/198 • Baseline up to Week 57 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.	5.1% 10/196 • Baseline up to Week 57 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.	0.51% 1/198 • Baseline up to Week 57 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.
Infections and infestations Nasopharyngitis	9.6% 19/198 • Baseline up to Week 57 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.	13.8% 27/196 • Baseline up to Week 57 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.	5.6% 11/198 • Baseline up to Week 57 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.
Infections and infestations Upper respiratory tract infection	6.6% 13/198 • Baseline up to Week 57 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.	6.1% 12/196 • Baseline up to Week 57 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.	3.5% 7/198 • Baseline up to Week 57 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.
Investigations Blood creatine phosphokinase increased	3.0% 6/198 • Baseline up to Week 57 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.	6.6% 13/196 • Baseline up to Week 57 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.	2.0% 4/198 • Baseline up to Week 57 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.
Metabolism and nutrition disorders Hypercholesterolaemia	2.0% 4/198 • Baseline up to Week 57 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.	5.6% 11/196 • Baseline up to Week 57 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.	1.0% 2/198 • Baseline up to Week 57 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.
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 17/198 • Baseline up to Week 57 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.	8.7% 17/196 • Baseline up to Week 57 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.	9.6% 19/198 • Baseline up to Week 57 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.
Nervous system disorders Headache	8.6% 17/198 • Baseline up to Week 57 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.	3.1% 6/196 • Baseline up to Week 57 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.	6.1% 12/198 • Baseline up to Week 57 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.
Skin and subcutaneous tissue disorders Rash	3.0% 6/198 • Baseline up to Week 57 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.	5.6% 11/196 • Baseline up to Week 57 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.	4.0% 8/198 • Baseline up to Week 57 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.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
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