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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00265122 |
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 |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | October 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
biologic Crohn's Disease injection infusion |
Antibodies, Monoclonal Antibodies Interleukin-12 Digestive System Diseases Gastrointestinal Diseases |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Immunoglobulins |