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

NCT00269841 | Completed Phase 3

• 1 other identifier: CR006253
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Keywords

fistulae; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3

  Number patients with 50% or more reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits that is not accompanied by initiation of a therapeutic agent or increase in dose.

  Week 3

Secondary Outcomes (1)

• Percentage of patients achieving a complete response at week 52

  Week 52

Study Arms (3)

Infliximab 10 mg/kg

EXPERIMENTAL

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

Drug: Infliximab 10 mg/kg

Infliximab 5 mg/kg

EXPERIMENTAL

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

Drug: Infliximab 5 mg/kg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Infliximab 10 mg/kg 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.

Also known as: anti-TNF chimeric monoclonal antibody (cA2)

Infliximab 10 mg/kg

Infliximab 5 mg/kg DRUG

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

Also known as: anti-TNF chimeric monoclonal antibody (cA2)

Infliximab 5 mg/kg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (1)

• 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.

  PMID: 10228190 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: May 1, 1996
• Primary Completion: February 1, 1998
• Study Completion: February 1, 1998
• Last Updated: November 4, 2014

Record last verified: 2014-11