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Sponsors and Collaborators: |
Elan Pharmaceuticals Biogen Idec |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00032786 |
The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: natalizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, International, Multicenter, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).
Study ID Numbers: | CD303 |
Study First Received: | April 3, 2002 |
Last Updated: | May 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00032786 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |