SONIC Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease
Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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.
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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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)
Locations and Contacts
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