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Sponsors and Collaborators: |
Elan Pharmaceuticals Biogen Idec |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00801125 |
The purpose of this study is to demonstrate the safety, tolerability and clinical benefit of TYSABRI® (natalizumab) in patients with moderately to severely active Crohn's disease.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: TYSABRI (natalizumab) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy |
Estimated Enrollment: | 100 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Initial treatment with an approved anti-TNF-α therapy, specifically infliximab, adalimumab, or certolizumab, who had either a primary or secondary treatment failure, or intolerance, to those agents;
A primary treatment failure is defined as one of the following:
Secondary failures to a single anti-TNF-α agent is defined as:
Secondary failures to two anti-TNF-α agents is defined as:
Exclusion Criteria:
Patients who do not meet any of the following criteria regarding baseline medications for CD (Please note that the term "Week 0" below refers to the exact day of the baseline visit):
Responsible Party: | Elan Pharmaceuticals ( Ahmed Hamdy/Senior Director, Clinical Development ) |
Study ID Numbers: | ELN51-309-503, CD FACTOR |
Study First Received: | December 1, 2008 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00801125 History of Changes |
Health Authority: | United States: Institutional Review Board |
Crohn's Disease Digestive System Diseases Gastrointestinal Diseases Ileitis Enteritis |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Ileal Diseases |
Digestive System Diseases Gastrointestinal Diseases Ileitis Enteritis Crohn Disease |
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Ileal Diseases |