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21O’Connor et. al (2006)28

MethodsPhase 2, multi-centre, double-blind, randomized, placebo-controlled trial.
Participants179 patients were enrolled at centres in Canada.
Inclusion criteria: Age = 18 years to 65 years, with RRMS (n = 157) or secondary-progressive MS with relapses (n = 22) (Poser et al.), EDSS = 0 to 6.0; had ≥ 2 documented relapses in previous 3 years, and one clinical relapse during the preceding year.
Exclusion criteria: Prior treatment with IFN, gamma-globulin, glatiramer, or other non-corticosteroid immunomodulatory therapies in the 4 months prior to the trial.
InterventionsPatients were randomly assigned (1:1:1) to receive placebo or teriflunomide at 7 mg or 14 mg for 36 weeks.
Teriflunomide oral 7 mg q.d. (n = 61)
Teriflunomide oral 14 mg q.d. (n = 57)
Placebo (n=61)
OutcomesPrimary end point: Number of combined unique active (new and persisting) lesions per MRI scan during 36 weeks.
Secondary end points: Other MRI outcomes, number of patients experienced relapses, annualized relapse rate, number of relapsing patients required a course of steroids, EDSS change.
DefinitionsRelapses: The appearance of a new symptom or worsening of an old symptom due to MS lasting 48 hours in the absence of fever, preceded by period of stability of at least 30 days and accompanied by appropriate changes on neurologic examination.
Treatment historyTreatment-naive (based in exclusion criteria, year of study, and clinical expert input).

From: APPENDIX 9, CHARACTERISTICS OF INCLUDED STUDIES

Cover of Management of Relapsing-Remitting Multiple Sclerosis
Management of Relapsing-Remitting Multiple Sclerosis [Internet].
CADTH Therapeutic Review, No. 1.2.
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