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A Study of the Safety and Efficacy of C01275 in Subjects With Crohn's Disease
This study has been completed.
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00265122
  Purpose

The purpose of this study is to examine the safety and efficacy of C01275 in subjects with active Crohn's Disease


Condition Intervention Phase
Crohn Disease
Drug: C01275
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
Drug Information available for: Immunoglobulins Globulin, Immune Interleukin-12
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (C01275) in Subjects With Moderately to Severely Active Crohn's Disease

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The primary endpoint is clinical response at Week 8 for Population 1. Clinical response is defined as a reduction in the CDAI score of = 25% and = 70 points.

Secondary Outcome Measures:
  • Clinical response following treatment with intravenous or subcutaneous C01275 for Population 1;Clinical response at Week 8 for Population 2;Serum C01275 profile and pharmacokinetic (PK) parameters of a single 5 mg/kg intravenous infusion, at 4 weeks

Estimated Enrollment: 120
Study Start Date: April 2004
Estimated Study Completion Date: October 2006
Detailed Description:

This study is a double-blind, placebo-controlled study. A total of approximately 120 patients will participate in this study in Canada, Belgium, and the United States. There will be 2 separate groups of patients evaluated in this study, Population 1 and Population 2. The 100 patients in this study who are considered Population 1 will be patients who still have active Crohn's disease despite treatment with standard Crohn's disease medications, including 5-ASA medications (for example: Pentasa®, Asacol®), corticosteroids (for example: prednisone) and/or other drugs known to suppress the immune system such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab (Humira®). The other 20 patients in the study are considered Population 2. These patients will receive infliximab (Remicade®) administered at the maximum dose described in the approved instructions for using infliximab (Remicade®). Infliximab (Remicade®) is another type of antibody that also works to decrease inflammation and works for many patients with moderate to severe Crohn's disease.

Population 1 will be randomized into 1of 4 treatment groups that receive either by an injection of 100 mg C01275 or placebo at weeks 0, 1, 2, 3, 8, 9, 10 and 11 or an infusion of 5 mg/kg C01275 or placebo at weeks 0 and 8. Subjects in Population 2 receive either an injection of 100 mg C01275 at weeks 0, 1, 2 and 3 or an infusion of 5 mg/kg of C01275 at week 0.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration

Exclusion Criteria:

  • Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
  • Had intra-abdominal surgery within 6 months prior to entering the study
  • Have received treatment with parenteral nutrition (total parenteral nutrition [TPN]) within 6 weeks of baseline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265122

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

Publications indexed to this study:
Study ID Numbers: CR005287
Study First Received: December 13, 2005
Last Updated: October 19, 2007
ClinicalTrials.gov Identifier: NCT00265122  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Interleukin-12
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on January 16, 2009