Crohn's Disease Clinical Trial
Official title:
A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)
The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.
The current approach to the treatment of Crohn's Disease is based on "step care". This
strategy is relatively ineffective for the long-term management of patients who require
treatment with corticosteroids. Although azathioprine, methotrexate and infliximab are
modestly effective in this high-risk population, long-term corticosteroid-free response
rates are low. Thus combination therapy is an attractive option to explore. Based on a
favourable experience with dual therapy in the treatment of rheumatoid arthritis and the
demonstrated efficacy of methotrexate in corticosteroid-dependent CD, we expect that
combination therapy with methotrexate and infliximab will be significantly more effective
than infliximab monotherapy. Furthermore combined therapy is likely to be highly effective
in preventing formation of the antibodies to infliximab that are an important limitation to
the continued successful use of this drug.
This is a randomized, placebo-controlled, double-blind, parallel group, multi-centre study.
Subjects who have initiated corticosteroid induction therapy within the preceding 6 weeks
will be randomized (irrespective of CDAI defined disease activity) in a 1:1 ratio to either
methotrexate or placebo for a period of 50 weeks in combination with infliximab administered
for 8 infusions. Randomization will be stratified by:
- Treatment with or without Imuran/6-mercaptopurine in the 2-12 months prior to
randomization;
- Prednisone dose <20 mg or ≥20 mg daily at randomization;
- CDAI <150 or ≥150 at randomization.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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