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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT00094458

Run by

Centocor Ortho Biotech Services, L.L.C.

People needed

508

Starts

2005-03-01

Expected to finish

2009-12-01

Last updated by the study team

2017-02-09

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Orange, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Golden, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Austell, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Peoria, Illinois, United States
• Study site — Clive, Iowa, United States
• Study site — Overland Park, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Troy, Michigan, United States
• Study site — Plymouth, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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