Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00475865|
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : November 2, 2012
Last Update Posted : November 6, 2012
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: Placebo (for teriflunomide)
Drug: Glatiramer Acetate (GA)
The recruitment initiated in April 2007 was completed in December 2008.
A total of 148 patients were screened at 24 sites in 6 countries.
Randomization was stratified by country.
Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria.
123 participants were randomized.