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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00303381 |
The purpose of this study is to determine the safety and efficacy of interferon beta-1a in patients with active ulcerative colitis.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Interferon beta-1a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose-Finding Phase II Study of Subcutaneously Administered IFN Beta 1a in the Treatment of Patients With Moderately Active Ulcerative Colitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Medical Information Office | |
Munich, Germany | |
Israel | |
Medical Information Office | |
Ness Ziona, Israel | |
Netherlands | |
Medical Information Office | |
Den Haag, Netherlands | |
Singapore | |
Medical Information Office | |
Singapore, Singapore | |
Spain | |
Medical Information Office | |
Madrid, Spain | |
Sweden | |
Medical Information Office | |
Solna, Sweden | |
Switzerland | |
Medical Information Office | |
Zug, Switzerland | |
United Kingdom | |
Medical Information Office | |
Feltham, United Kingdom |
Study Director: | Claudia Pena Rossi, M.D. | EMD Serono |
Study ID Numbers: | 22648 |
Study First Received: | March 14, 2006 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00303381 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunologic Factors Gastrointestinal Diseases Ulcer Colonic Diseases Interferons Adjuvants, Immunologic Interferon-beta Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Antiviral Agents Signs and Symptoms Digestive System Diseases Interferon beta 1a Gastroenteritis Colitis |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Ulcer Physiological Effects of Drugs Colonic Diseases Interferons Adjuvants, Immunologic Interferon-beta Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Antiviral Agents Pharmacologic Actions Digestive System Diseases Pathologic Processes Therapeutic Uses Interferon beta 1a Gastroenteritis Colitis |