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Sponsors and Collaborators: |
EMD Serono Pfizer |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00078338 |
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 mcg three times per week compared with Copaxone® 20 mg daily in patients with relapsing Multiple Sclerosis.
Condition | Intervention | Phase |
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Relapsing-Remitting Multiple Sclerosis |
Drug: Human interferon beta-1a and glatiramer acetate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1).
Study Director: | Bruno Musch, MD | EMD Serono |
Study ID Numbers: | 24735 |
Study First Received: | February 23, 2004 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00078338 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Interferons Adjuvants, Immunologic Interferon-beta Sclerosis Immunosuppressive Agents |
Multiple Sclerosis, Relapsing-Remitting Antiviral Agents Copolymer 1 Multiple Sclerosis Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Interferon-beta Sclerosis |
Immunosuppressive Agents Antiviral Agents Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Therapeutic Uses Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |