The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
593
Placebo 10 mg orally (PO) twice a day (BID)
CP-690,550 5 mg orally (PO) twice a day (BID)
CP-690,550 10 mg orally (PO) twice a day (BID)
Percentage of Participants In Remission at Week 52
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
Percentage of Participants With Mucosal Healing at Week 52
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
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
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.
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Time frame: Week 24, 52
Percentage of Participants in Remission at Week 24
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
Percentage of Participants in Sustained Remission
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
Percentage of Participants With Mucosal Healing at Week 24
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
Percentage of Participants With Sustained Mucosal Healing
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
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
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
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
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
Percentage of Participants With Clinical Response at Week 24 and 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 clinical response at Week 24 and 52 have been reported in this outcome measure.
Time frame: Week 24, 52
Percentage of Participants With Sustained Clinical Response
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
Percentage of Participants in Clinical Remission at Week 24 and 52
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
Percentage of Participants in Sustained Clinical Remission
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
Percentage of Participants in Deep Remission at Week 24 and 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
Percentage of Participants in Sustained Deep Remission
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
Percentage of Participants in Symptomatic Remission at Week 24 and 52
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
Percentage of Participants in Sustained Symptomatic Remission
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
Percentage of Participants in Endoscopic Remission at Week 24 and 52
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
Percentage of Participants in Sustained Endoscopic Remission
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
Total Mayo Score at Baseline, Week 24 and 52
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
Change From Baseline in Total Mayo Score at Week 24 and 52
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
Percentage of Participants in Remission, Among Participants With Remission at Baseline
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
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
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
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
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
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
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
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
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