Status:
COMPLETED
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
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Collaborating Sponsors:
Schering-Plough
Conditions:
Crohn Disease
Eligibility:
All Genders
21-99 years
Phase:
PHASE3
Brief 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 co...
Detailed Description
Crohns disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated with medications...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00094458
Start Date
March 1 2005
End Date
December 1 2009
Last Update
February 9 2017
Active Locations (115)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
3
Orange, California, United States
4
Roseville, California, United States