CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 508 enrolled
Drug / intervention
infliximab infusion; AZA placebo caps +2 morebiological
Likely dose
Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22; Azathioprine 2.5 mg/kg/dayAI-extracted
Key inclusion· 4
  • ✓Confirmed Crohn's Disease diagnosis for at least 6 weeks
  • ✓Moderate to severe disease activity (CDAI 220-450)
  • ✓Naive to azathioprine, 6-MP, and biologic therapies
  • ✓Corticosteroid-dependent, refractory, or candidate for repeated corticosteroid courses
Key exclusion· 7
  • ✕Abdominal surgery within 6 months prior to enrollment
  • ✕Presence of ostomy or stoma
  • ✕Pregnancy, nursing, or planning pregnancy
  • ✕Serious concurrent illness that could interfere with study participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00094458
NCT00094458Phase 3Completed
CompareCT.gov

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

Centocor Ortho Biotech Services, L.L.C.·interventional·Posted Oct 20, 2004·Updated Feb 9, 2017

In Brief

A Phase 3 clinical trial evaluating infliximab infusion; AZA placebo caps, infliximab (IFX) infusion; azathioprine (AZA) caps, and 1 other intervention for Crohn Disease. Completed, enrolled 508 participants across 115 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesAustria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2004
Enrollment StartMar 1, 2005
Primary CompletionApr 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 21.7 years ago

Interventions

infliximab infusion; AZA placebo capsbiological

Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules

infliximab (IFX) infusion; azathioprine (AZA) capsother

AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22

infliximab (IFX) placebo infusion; azathioprine (AZA) capsdrug

AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22