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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00112034 |
The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Methotrexate Drug: IV methylprednisolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy. |
Estimated Enrollment: | 350 |
Study Start Date: | June 2003 |
Study Completion Date: | May 2007 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biogen Idec ( Dennis Cunningham, Associate Director, Medical Affairs ) |
Study ID Numbers: | C-865 |
Study First Received: | May 27, 2005 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00112034 |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Relapsing-Remitting AVONEX Combination Methotrexate |
IV Methylprednisolone IVMP ACT MTX |
Autoimmune Diseases Demyelinating Diseases Methylprednisolone Interferons Interferon-beta Methylprednisolone acetate Prednisolone acetate Sclerosis Demyelinating diseases |
Multiple Sclerosis, Relapsing-Remitting Folic Acid Multiple Sclerosis Prednisolone Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Methotrexate Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Neuroprotective Agents Pathologic Processes Therapeutic Uses Abortifacient Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Hormonal Immune System Diseases Nervous System Diseases Adjuvants, Immunologic Gastrointestinal Agents Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Glucocorticoids Protective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents |