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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00168766 |
The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.
Condition | Intervention | Phase |
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Relapsing-Remitting Multiple Sclerosis |
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-Beta-1a for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis |
Estimated Enrollment: | 345 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
interferon-beta-1a in combination with methylprednisolone
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Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
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2: Placebo Comparator
interferon-beta-1a in combination with placebo
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Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
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Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
CUB Hôpital Erasme | |
Bruxelles, Belgium, B-1070 | |
Denmark | |
Rigshospitalet | |
Skleroseklinikken, Denmark, N2082 | |
Finland | |
Tampereen yliopistollinen sairaala - Neurologian klinikka | |
Tampere, Finland, FIN-33521 | |
Netherlands | |
Stichting MS Centrum | |
Nijemegen, Netherlands, NL-6533 | |
Norway | |
Ullevål Universitetssykehus | |
Oslo, Norway, 0407 | |
Sweden | |
Neurologkliniken | |
Stockholm, Sweden, 171 76 | |
Switzerland | |
Kantonspital | |
St. Gallen, Switzerland, 9007 | |
United Kingdom, NG7 2UH | |
Queens Medical Centre - Division of Neurology | |
Nottingham, NG7 2UH, United Kingdom |
Principal Investigator: | Mads Ravnborg | Rigshospitalet, Denmark |
Responsible Party: | Biogen Idec International ( Biogen Idec MD, Nordic Medical Director ) |
Study ID Numbers: | NOR-03-01, Mecombin |
Study First Received: | September 13, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00168766 |
Health Authority: | Denmark: Danish Medicines Agency |
Combination therapy for multiple sclerosis |
Interferon Type I, Recombinant Autoimmune Diseases Demyelinating Diseases Methylprednisolone Interferons Interferon-beta Methylprednisolone acetate Prednisolone acetate Sclerosis |
Demyelinating diseases Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis Prednisolone Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Neuroprotective Agents Hormones Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents, Hormonal |
Immune System Diseases Growth Substances Nervous System Diseases Adjuvants, Immunologic Gastrointestinal Agents Angiogenesis Inhibitors Antiviral Agents Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |