18Johnson et al. (1995)26

MethodsMulti-centre, double-blind, randomized, placebo-controlled trial.
Participants251 patients were enrolled at 11 centres in the US.
Inclusion criteria: Age = 18 years to 45 years, clinically definite RRMS (Poser et al.), EDSS = 0 to 5.0; had ≥ 2 clinically documented relapses in the 2 years before entry; onset of the first relapse at least 1 year before randomization; and a period of neurologic stability and freedom from corticosteroid therapy of at least 30 days prior to entry.
Exclusion criteria: Received copolymer 1 or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine) or lymphoid irradiation; pregnancy or lactation; insulin-dependent diabetes mellitus, positive HIV or HTL V-I serology, evidence of Lyme disease, or required use of aspirin or chronic nonsteroidal antiinflammatory drugs during the course of the trial.
InterventionsPatients were randomly assigned (1:1) to receive glatiramer acetate or placebo for 24 months.
Glatiramer acetate 20 mg SC q.d. (n = 125)
Placebo (n = 126)
OutcomesPrimary end points: Relapse rate over 24 months, annualized relapse rate, number of relapse over 24 months.
Secondary end points: Proportion of relapse-free patients, median time to first relapse, number of relapse per patient, proportion of patients with a change in disability, EDSS change, proportion of progression-free patients, ambulation index.
DefinitionsRelapses: The appearance or reappearance of one or more neurologic abnormalities persisting for at least 48 hours and immediately proceeded by a relatively stable or improving neurologic state of at least 30 days.
Disability progression: An increase of at least one full step on the EDSS that persisted of at least 3 months.
Treatment historyTreatment-naive (based on exclusion criteria, year of study, and clinical expert input).

From: APPENDIX 9, CHARACTERISTICS OF INCLUDED STUDIES

Cover of Comparative Clinical and Cost-Effectiveness of Drug Therapies for Relapsing-Remitting Multiple Sclerosis
Comparative Clinical and Cost-Effectiveness of Drug Therapies for Relapsing-Remitting Multiple Sclerosis [Internet].
CADTH Therapeutic Review, No. 1.2B.
Copyright © CADTH March 2013.

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