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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00537316 |
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.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Biological: Infliximab Drug: Azathioprine Drug: Azathioprine / Infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
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) |
Estimated Enrollment: | 600 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Infliximab 5 mg/kg IV: Experimental |
Biological: Infliximab
Subjects in the infliximab monotherapy cohort will receive infliximab IV infusions at Weeks 0, 2, and 6. Subjects responding to infliximab treatment at Week 8, 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. |
AZA 2.5 mg/kg: Active Comparator |
Drug: Azathioprine
Subjects will receive azathioprine at 2.5 mg per kg body weight per day orally; AZA treatment will remain double-blinded in all cohorts throughout Parts 1 and 2 except for direct entry into Part 2. 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.
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AZA 2.5 mg/kg + Infliximab 5 mg/kg IV: Experimental |
Drug: Azathioprine / Infliximab
Subjects in the infliximab/AZA combination therapy cohort will receive infliximab IV infusions at Weeks 0, 2, and 6 and daily oral AZA. Subjects responding to infliximab/AZA treatment at Week 8will 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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are considered eligible according to the following tuberculosis (TB) screening criteria:
Exclusion Criteria:
Subjects have severe extensive colitis as evidenced by:
Subjects with at least 4 of these symptoms at Screening or Baseline visits, as follows:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04807 |
Study First Received: | September 28, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00537316 History of Changes |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Anti-Inflammatory Agents Antimetabolites Immunologic Factors Gastrointestinal Diseases Infliximab Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Immunosuppressive Agents Digestive System Diseases Azathioprine Antirheumatic Agents Gastroenteritis Colitis |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Infliximab Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Inflammatory Bowel Diseases Azathioprine Pathologic Processes |
Therapeutic Uses Dermatologic Agents Ulcer Gastrointestinal Agents Colitis, Ulcerative Intestinal Diseases Immunosuppressive Agents Pharmacologic Actions Digestive System Diseases Gastroenteritis Antirheumatic Agents Colitis |