At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 128 enrolled
Drug / intervention
Methotrexate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Methotrexate and Placebo for Crohn's Disease. Completed, enrolled 128 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesCanada
CollaboratorsSchering-Plough
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartDec 2005
Primary CompletionFeb 2008
Study CompletionJul 2008
TodayJul 2026
First PostedAug 22, 2005
Enrollment StartDec 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.9 years ago
Interventions
Methotrexatedrug
Methotrexate and infliximab combination
Placebodrug
Placebo and infliximab combination therapy.