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

NCT00269854 | Completed Phase 2

• 1 other identifier: CR006256
• Study Type: interventional
• Target: 108
• 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 patients with active Crohn's disease.

Conditions

Crohn Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of the proportion of patients achieving a clinical response at Week 4

  Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points.

  Week 4

Secondary Outcomes (1)

• Clinical response over time; Time to loss of response; Clinical remission over time; Changes in CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ) and Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values

  up to Week 48

Study Arms (4)

Infliximab 5 mg/kg

EXPERIMENTAL

Drug: Infliximab 5 mg/kg

Infliximab 10 mg/kg

EXPERIMENTAL

Drug: Infliximab 10 mg/kg

Infliximab 20 mg/kg

EXPERIMENTAL

Drug: Infliximab 20 mg/kg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Infliximab 5 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 5 mg/kg

Infliximab 10 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 10 mg/kg

Infliximab 20 mg/kg DRUG

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6.

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

Infliximab 20 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 6 months duration, with colitis, ileitis, or ileocolitis confirmed by radiography or endoscopy
• Having a Crohn's Disease Activity Index (CDAI) of \>=220 and \<=400
• Treated with at least 1 of the following: current use of oral corticosteroid therapy of \<=40 mg/day (prednisone equivalent), current use of (or lack of response to) \>=2 g/day of sulfasalazine (or equivalent) or \>=800 mg of mesalamine, current use of (or lack of response to) azathioprine or 6-mercaptopurine, failure to respond to methotrexate or cyclosporine, (with a stop date at least 3 months prior to screening)
• If using oral corticosteroids, sulfasalazine or mesalamine, a start date at least 8 weeks prior to screening, with a stable dose of sulfasalazine or mesalamine for at least 4 weeks prior to screening and a stable dose of oral corticosteroids for at least 2 weeks prior to screening
• If not currently using oral corticosteroids, a stop date of any previous corticosteroid regimen of at least 4 weeks prior to screening and if not using sulfasalazine, mesalamine, azathioprine or 6-mercaptopurine, a stop date of any previous treatment with these agents of at least 8 weeks prior to screening

You may not qualify if:

• Patients with Crohn's disease limited to the stomach or proximal small intestine
• Having symptomatic stenosis or ileal strictures that might have require surgical intervention or that might render patients unresponsive to cA2 treatment
• Who have received treatment with parenteral corticosteroid or adrenocorticotrophic hormone within 4 weeks prior to screening, or currently requiring oral or parenteral corticosteroid therapy for another disease such as asthma
• Having a serious infection, such as hepatitis, pneumonia or pyelonephritis in the 3 months prior to screening, 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
• Having active signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease, or any current known malignancy or any history of malignancy which would put the patient at an unacceptable risk for participation in the study or that would be expected to limit life expectancy

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (1)

• Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997 Oct 9;337(15):1029-35. doi: 10.1056/NEJM199710093371502.

  PMID: 9321530 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 2
• 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: June 1, 1995
• Primary Completion: October 1, 1996
• Study Completion: October 1, 1996
• Last Updated: November 4, 2014

Record last verified: 2014-11