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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269854
First received: December 22, 2005
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Crohn Disease
Drug: Infliximab 5 mg/kg
Drug: Infliximab 10 mg/kg
Drug: Infliximab 20 mg/kg
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Comparison of the proportion of patients achieving a clinical response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points.


Secondary Outcome Measures:
  • 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 [ Time Frame: up to Week 48 ]

Enrollment: 108
Study Start Date: June 1995
Study Completion Date: October 1996
Primary Completion Date: October 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab 5 mg/kg Drug: Infliximab 5 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.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Experimental: Infliximab 10 mg/kg Drug: Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Experimental: Infliximab 20 mg/kg Drug: Infliximab 20 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Placebo Comparator: Placebo Drug: Placebo
Matching placebo will be adminstered at Week 0, 2 and 6.

Detailed Description:

This is a randomized, placebo-controlled, double-blind, dose-ranging study followed by a placebo-controlled, double-blind, repeated-dose extension to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with active Crohn's disease. The primary efficacy outcome of the study is a comparison of the proportion of patients achieving a clinical response at the 4-week evaluation. Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points. Additional measurements of effectiveness include the clinical response over time, the time to loss of response, clinical remission over time, and changes in the Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values.

Anti-TNF Chimeric Monoclonal Antibody (cA2) or placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269854

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Publications:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00269854     History of Changes
Other Study ID Numbers: CR006256
Study First Received: December 22, 2005
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014