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

Recruiting in Palo Alto (17 mi)

+115 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Centocor Ortho Biotech Services, L.L.C.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Centocor Ortho Biotech Services, L.L.C. Clinical Trial

Principal Investigator

Centocor Ortho Biotech Services, L.L.C.

Eligibility 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

Treatment Details

Interventions

• Azathioprine (Immunosuppressant)
• Infliximab (Monoclonal Antibodies)

Participant Groups

Group I: 003 Experimental Treatment 1 Intervention

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

Group II: 002 Experimental Treatment 1 Intervention

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

Group III: 001 Experimental Treatment 1 Intervention

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

Azathioprine is already approved in Canada for the following indications:

Approved in Canada as Imuran for:

• Prevention of rejection in organ transplantation
• Treatment of rheumatoid arthritis

Who Is Running the Clinical Trial?

Centocor Ortho Biotech Services, L.L.C.

Lead Sponsor

Trials

18

Recruited

3,800+

Schering-Plough

Industry Sponsor

Trials

163

Recruited

41,500+

Fred Hassan

Schering-Plough

Chief Executive Officer since 2003

PhD in Organic Chemistry from Harvard University

Dr. Robert J. Spiegel

Schering-Plough

Chief Medical Officer since 2006

MD from the University of Pennsylvania