Official Title: “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”

This is a medical research study for patients with Crohn's disease who have failed to respond to certain drugs called 5-ASA drugs (e.g. Asacol, Pentasa, sulfasalizine) and/or require frequent treatment with corticosteriods.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Crohn's disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. It is generally treated with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other symptoms of Crohn's disease. In addition, Crohn's disease can be treated with medications that suppress the immune system (the body system involved in inflammation and infections) or with surgery. This study will investigate the effectiveness of REMICADE® (infliximab) and Imuran® (the generic name is azathioprine) in the treatment of patients with moderate-to-severe Crohn's disease. REMICADE® is currently approved by the FDA for the treatment of both Crohn's disease and rheumatoid arthritis. Azathioprine, which is an investigational drug, has not been approved by the FDA for the treatment of Crohn's disease, but it is a well-established therapy that has been used for many years to treat Crohn's disease. This study seeks to determine whether REMICADE®, azathioprine, or the combination of both drugs would be the most appropriate treatment for Crohn's disease patients who have not responded well to certain drugs called 5-ASA drugs (e.g. Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids. This research study will involve approximately 500 patients. Patients may participate in the main study for up to 34 weeks (approximately 8 months). During the main study, patients will be asked to visit the study center for 10 visits. If patients enroll into the extension of the study, the total time for participation may be up to 54 weeks (approximately 13 months). Patients enrolled in the Study Extension will be asked to visit the study center for an additional 5 visits.

Patients will be assigned to one of three treatment groups (either infliximab plus placebo capsules, infliximab plus azathioprine, or azathioprine plus placebo infusions - there is no possibility of being assigned to placebo only in this trial - patients will receive one or both of these medications) at the beginning of the study. Oral medication will be taken daily. There are 5 infusion (which will be either infliximab or placebo) visits during the main study.

Intervention(s) in this Clinical Trial

• Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
  • AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
• Biological: infliximab infusion; AZA placebo caps
  • Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
• Other: infliximab (IFX) infusion; azathioprine (AZA) caps
  • AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
• Experimental: 002
• Experimental: 003

Primary Measures

• The primary outcome measure is corticosteriod free remission at week 26.
  • Time Frame: Week 26
    Safety Issue?: No

Secondary Measures

• The secondary outcome measure is mucosal healing at Week 26.
  • Time Frame: Mucosal healing - at Week 26; Remission without steroids for 3 weeks - at Week 50; Clinical Response - through Week 50; Remission - through Week 50; QOL - through Week 50; Corticosteroid dose - through Week 50; Safety - through Week 54.
    Safety Issue?: No

Inclusion Criteria:

• 18 years of age or older
• Diagnosis of Crohn's Disease for at least 6 weeks
• Moderate to severe disease activity (CDAI >= 220 and <=400)
• No history of azathioprine, 6-MP, or biologic treatments
• Are either Corticosteriod-dependent, Or considered for a 2nd (or greater) course of corticosteriod, Or 5-ASA failures, Or Budesonide failures

Exclusion Criteria:

• Have had intra-abdominal surgery within 6 months
• Have an ostomy or stoma
• Are pregnant, nursing, or planning pregnancy (both men and women)
• Have a serious concomitant illness that could interfere with the patient's participation
• Have used any investigational drug within 30 days
• Have a concomitant diagnosis or any history of congestive heart failure
• Weigh more than 140 kg (310 lbs)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centocor, Inc.

Overall Clinical Trial Officials and Contacts

Centocor, Inc. Clinical Trial Study Director Centocor, Inc.  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00094458

Study ID Number: CR004804

ClinicalTrials.gov Identifier: NCT00094458

Health Authority: United States: Food and Drug Administration

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm