SONIC Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease

Condition(s) targeted: Crohn's Disease

Intervention: infliximab (IFX) placebo infusion; azathioprine (AZA) caps (Drug); infliximab infusion; AZA placebo caps (Biological); infliximab (IFX) infusion; azathioprine (AZA) caps (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Centocor, Inc.

Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.

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.

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

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

Primary outcome: The primary outcome measure is corticosteriod free remission at week 26.

Secondary outcome: The secondary outcome measure is mucosal healing at Week 26.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

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

Starting date: March 2005
Ending date: November 2008
Last updated: February 28, 2008