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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01458574
Registration number
NCT01458574
Ethics application status
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
18/05/2017
Titles & IDs
Public title
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
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Scientific title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
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Secondary ID [1]
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2011-004580-79
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Secondary ID [2]
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A3921096
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Universal Trial Number (UTN)
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Trial acronym
OCTAVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP690,550
Treatment: Drugs - CP-690,550
Placebo Comparator: Placebo Comparator -
Experimental: CP-690,550 5 mg Arm -
Experimental: CP-690,550 10 mg Arm -
Treatment: Drugs: Placebo
Placebo 10 mg orally (PO) twice a day (BID)
Treatment: Drugs: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
Treatment: Drugs: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants In Remission at Week 52
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Assessment method [1]
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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.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants With Mucosal Healing at Week 52
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Assessment method [1]
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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.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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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
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Assessment method [2]
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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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Timepoint [2]
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Week 24, 52
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Secondary outcome [3]
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Percentage of Participants in Remission at Week 24
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Assessment method [3]
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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.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Percentage of Participants in Sustained Remission
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Assessment method [4]
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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.
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Timepoint [4]
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Week 24, 52
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Secondary outcome [5]
0
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Percentage of Participants With Mucosal Healing at Week 24
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Assessment method [5]
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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.
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Percentage of Participants With Sustained Mucosal Healing
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Assessment method [6]
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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.
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Timepoint [6]
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Week 24, 52
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Secondary outcome [7]
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Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
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Assessment method [7]
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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.
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Timepoint [7]
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Week 24, 52
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Secondary outcome [8]
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Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
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Assessment method [8]
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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.
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Timepoint [8]
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Week 24, 52
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Secondary outcome [9]
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Percentage of Participants With Clinical Response at Week 24 and 52
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Assessment method [9]
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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.
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Timepoint [9]
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Week 24, 52
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Secondary outcome [10]
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Percentage of Participants With Sustained Clinical Response
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Assessment method [10]
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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.
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Timepoint [10]
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Week 24, 52
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Secondary outcome [11]
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Percentage of Participants in Clinical Remission at Week 24 and 52
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Assessment method [11]
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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.
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Timepoint [11]
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Week 24, 52
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Secondary outcome [12]
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Percentage of Participants in Sustained Clinical Remission
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Assessment method [12]
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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.
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Timepoint [12]
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Week 24, 52
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Secondary outcome [13]
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Percentage of Participants in Deep Remission at Week 24 and 52
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Assessment method [13]
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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.
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Timepoint [13]
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Week 24, 52
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Secondary outcome [14]
0
0
Percentage of Participants in Sustained Deep Remission
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Assessment method [14]
0
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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.
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Timepoint [14]
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Week 24, 52
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Secondary outcome [15]
0
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Percentage of Participants in Symptomatic Remission at Week 24 and 52
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Assessment method [15]
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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.
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Timepoint [15]
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Week 24, 52
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Secondary outcome [16]
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Percentage of Participants in Sustained Symptomatic Remission
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Assessment method [16]
0
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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.
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Timepoint [16]
0
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Week 24, 52
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Secondary outcome [17]
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Percentage of Participants in Endoscopic Remission at Week 24 and 52
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Assessment method [17]
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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.
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Timepoint [17]
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Week 24, 52
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Secondary outcome [18]
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Percentage of Participants in Sustained Endoscopic Remission
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Assessment method [18]
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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.
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Timepoint [18]
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Week 24, 52
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Secondary outcome [19]
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Total Mayo Score at Baseline, Week 24 and 52
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, Week 24, 52
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Secondary outcome [20]
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Change From Baseline in Total Mayo Score at Week 24 and 52
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Assessment method [20]
0
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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.
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Timepoint [20]
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Baseline, Week 24, 52
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Secondary outcome [21]
0
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Percentage of Participants in Remission, Among Participants With Remission at Baseline
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Assessment method [21]
0
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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.
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Timepoint [21]
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Week 24, 52
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Secondary outcome [22]
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Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
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Assessment method [22]
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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.
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Timepoint [22]
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Week 24, 52
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Secondary outcome [23]
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Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
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Assessment method [23]
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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.
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Timepoint [23]
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Week 24, 52
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Secondary outcome [24]
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Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
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Assessment method [24]
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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.
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Timepoint [24]
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Week 24, 52
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Secondary outcome [25]
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Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
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Assessment method [25]
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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.
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Timepoint [25]
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Week 24, 52
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Eligibility
Key inclusion criteria
- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study
enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely
to require surgery for UC during the study period.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/05/2016
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Sample size
Target
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Accrual to date
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Final
593
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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0
Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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0
Eastern Health-Box Hill Hospital - Box Hill
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Recruitment hospital [4]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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0
2139 - Concord
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Recruitment postcode(s) [2]
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0
2170 - Liverpool
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Alabama
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0
0
United States of America
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0
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California
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0
0
United States of America
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0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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0
Georgia
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0
0
United States of America
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0
Kansas
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0
0
United States of America
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Maryland
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0
United States of America
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Michigan
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United States of America
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Minnesota
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0
0
United States of America
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New Hampshire
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0
0
United States of America
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0
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New Jersey
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0
0
United States of America
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0
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New York
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0
0
United States of America
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North Carolina
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0
0
United States of America
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0
0
Ohio
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0
0
United States of America
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0
0
Pennsylvania
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0
0
United States of America
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0
Texas
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0
United States of America
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Utah
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0
United States of America
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Virginia
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0
United States of America
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Wisconsin
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Austria
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Vienna
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Belgium
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Antwerpen
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Belgium
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Kortrijk
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Belgium
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Leuven
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0
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Belgium
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Roeselare
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0
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Brazil
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Rio Grande Do Sul
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0
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Canada
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0
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Alberta
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0
0
Canada
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0
0
Ontario
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0
0
Canada
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0
0
Quebec
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0
0
Canada
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0
0
Saskatchewan
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0
0
Colombia
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0
0
Antioquia
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0
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Croatia
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Zagreb
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0
0
Czech Republic
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0
0
Hradec Kralove
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Czech Republic
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Strakonice
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Czech Republic
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Usti nad Labem
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Denmark
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Aalborg
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Denmark
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Aarhus C
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Denmark
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Copenhagen NV
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Denmark
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Denmark
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Tallinn
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Tallin
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France
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France
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France
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Clichy Cedex
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France
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Nantes cedex 01
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France
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Paris cedex 12
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France
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Paris
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France
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Reims cedex
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France
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Saint Priest en Jarez
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Germany
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Germany
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Halle
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Germany
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Hannover
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Germany
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Germany
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Minden
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Germany
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Ulm
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Hungary
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Hungary
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Budapest
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Debrecen
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Hungary
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Gyula
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Miskolc
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Hungary
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Mosonmagyarovar
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Vac
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Haifa
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Israel
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Israel
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Milano
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Italy
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PA
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Japan
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Japan
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Japan
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Japan
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Kochi
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Shiga
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Japan
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Tokyo
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Korea, Republic of
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Gyeonggi-do
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Republic of Korea
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Incheon
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Seoul
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Riga
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Bay of Plenty
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Novosibirsk,
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Russian Federation
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Novosibirsk
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Serbia
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Belgrade
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Lviv
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United Kingdom
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United Kingdom
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01458574
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Public notes
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Contacts
Principal investigator
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0
Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01458574
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