Status:
COMPLETED
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
Lead Sponsor:
Centocor, Inc.
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.
Detailed Description
This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment...
Eligibility Criteria
Inclusion
- Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy
- Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
- If treated with oral prednisone (or equivalent), the dose must be \<=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)
- If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)
Exclusion
- Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment
- Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment
- Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium
- Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- Currently having any known malignancy or any history of malignancy within the past 5 years
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1998
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00269841
Start Date
May 1 1996
End Date
February 1 1998
Last Update
November 4 2014
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