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Tracking Information | |||||
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First Received Date † | September 28, 2007 | ||||
Last Updated Date | April 14, 2009 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00537316 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807AM2) | ||||
Official Title † | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | ||||
Brief Summary | Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter, double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab, as monotherapy or in combination with AZA versus AZA monotherapy in adults with moderate to severe active UC. Subjects who qualify at the Baseline Visit will be eligible to be randomized to one of the three active treatment groups. Subjects in the infliximab/AZA combination therapy and infliximab monotherapy cohorts will receive infliximab infusions at Weeks 0, 2, and 6 and daily oral AZA/placebo, respectively; subjects in the AZA cohort will receive daily oral AZA and placebo infusions at Weeks 0, 2, and 6. At Week 8, all subjects will be evaluated for response. Subjects responding to infliximab treatment at Week 8, either as monotherapy or in combination with AZA, will receive one more infliximab infusion at Week 14; nonresponders to infliximab therapy will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14. Subjects responding to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; nonresponders to AZA will be eligible to receive infliximab at Weeks 8, 10, and 14. Part 2: Subjects in remission on infliximab monotherapy or infliximab/AZA treatment at Week 16 will be randomized to either maintenance or intermittent open-label infliximab treatment; randomization will be stratified based on oral AZA/placebo treatment in Part 1. Oral AZA/placebo treatment will continue to be double-blinded. All subjects will continue to receive oral AZA/ placebo for the duration of the study. In addition, to facilitate enrollment into Part 2, subjects who received treatment outside of Part 1 and who are in remission on infliximab with or without AZA/6-MP will be allowed to enter directly into Part 2. In the Czech Republic, direct entry into Part 2 of the study is not allowed. Subjects will be randomized to either maintenance or intermittent open -label infliximab treatment. Subjects will continue with open-label oral AZA/6-MP, if applicable. These subjects will be stratified based on oral AZA/6-MP use. Subjects randomized to maintenance infliximab treatment will receive scheduled infusions every 8 weeks beginning at Week 22 (Week 6 for direct entry). If subjects lose response, or if treatment has to be discontinued because of an adverse event, these subjects are considered treatment failures, and should be followed up for safety at the scheduled 6-month visits (Weeks 38, 62, and 94 [Weeks 22, 46, and 78 for direct entry]). These subjects will receive standard of care per their personal physician. Subjects randomized to intermittent infliximab treatment will be evaluated every 8 weeks. Subjects will receive infliximab only upon relapse of disease. Infliximab treatment will be initiated at Weeks 0, 2, and 6 of the individual treatment cycle and will continue every 8 weeks until remission is regained. Throughout the study, individual treatment cycles will be repeated whenever a subject relapses. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment | ||||
Condition † | Ulcerative Colitis | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 600 | ||||
Estimated Completion Date | July 2011 | ||||
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Argentina, Canada, Colombia, Czech Republic, Germany, Hungary, Italy, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Ukraine, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00537316 | ||||
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough | ||||
Secondary IDs †† | |||||
Study Sponsor † | Schering-Plough | ||||
Collaborators †† | |||||
Investigators † | |||||
Information Provided By | Schering-Plough | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |