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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00269841
Date of registration: 22/12/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
Scientific title: A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
Date of first enrolment: May 1996
Target sample size: 94
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Crohn's disease of at least 3 months duration confirmed by radiography

- 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

- 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 Criteria:

- 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: Infliximab 10 mg/kg
Drug: Infliximab 5 mg/kg
Drug: Placebo
Primary Outcome(s)
Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3 [Time Frame: Week 3]
Secondary Outcome(s)
Percentage of patients achieving a complete response at week 52 [Time Frame: Week 52]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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