An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

NCT ID: NCT00269841

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-05-31
• Study Completion Date: 1998-02-28

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 of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.

Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Infliximab 10 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.

Group Type: EXPERIMENTAL

Infliximab 10 mg/kg

Intervention Type: DRUG

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.

Infliximab 5 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.

Group Type: EXPERIMENTAL

Infliximab 5 mg/kg

Intervention Type: DRUG

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.

Placebo

Matching placebo will be administered at Week 0, 2 and 6.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be adminstered at Week 0, 2 and 6.

Interventions

Infliximab 10 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.

Intervention Type: DRUG

Infliximab 5 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.

Intervention Type: DRUG

Placebo

Matching placebo will be adminstered at Week 0, 2 and 6.

Intervention Type: DRUG

Other Intervention Names

anti-TNF chimeric monoclonal antibody (cA2); anti-TNF chimeric monoclonal antibody (cA2)

Eligibility Criteria

Inclusion Criteria

• 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 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 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

References

Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.

Reference Type: RESULT

PMID: 10228190 (View on PubMed)

Other Identifiers

CR006253

Identifier Type: -

Identifier Source: org_study_id