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Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
Details
| Lead sponsor | Centocor Ortho Biotech Services, L.L.C. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 508 |
| Start date | 2005-03 |
| Completion | 2009-12 |
Conditions
- Crohn Disease
Interventions
- infliximab infusion; AZA placebo caps
- infliximab (IFX) infusion; azathioprine (AZA) caps
- infliximab (IFX) placebo infusion; azathioprine (AZA) caps
Primary outcomes
- Percentage of Participants With Corticosteriod-free Clinical Remission — Week 26
Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (\<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (\>=) 3 weeks and have not received budesonide at a dose \> 6 milligram per day (mg/day) for \>= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Countries
United States, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom