COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

NCT00132899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2013-12-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate

Methotrexate and infliximab combination

DRUG

Placebo

Placebo and infliximab combination therapy.

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY
  • University of Western Ontario, Canada

    lead OTHER

Principal Investigators

  • Brian G Feagan, MD, M.Sc · Robarts Clinical Trials, Robarts Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-02-29
Completion
2008-07-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132899 on ClinicalTrials.gov