Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor Ortho Biotech Services, L.L.C.
• Collaborator: Schering-Plough
• Treatments: Adjuvants, Immunologic; Azathioprine; Immunologic Factors; Infliximab

Criteria

Inclusion Criteria:

• Diagnosis of Crohns Disease for at least 6 weeks

• Moderate to severe disease activity (CDAI >= 220 and <=450)

• No history of azathioprine, 6-MP (6 Mercaptopurine), 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:

• History of abdominal surgery within the last 6 months

• Have an ostomy or stoma [An operation to create an opening from an area inside the body to the outside]

• Are pregnant, nursing, or planning pregnancy (both men and women)

• Serious simultaneous illness that could interfere with study participation

• Use of any investigational drug within 30 days

• Have a concomitant diagnosis or any history of congestive heart failure

• Weigh more than 140 kilograms (or 310 pounds)