At a glance
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Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses
In Brief
A Phase 2 clinical trial evaluating Teriflunomide, Placebo (for teriflunomide), and 2 other interventions for Multiple Sclerosis. Completed, enrolled 182 participants across 7 sites in 7 countries.
Detailed Summary
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses. Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters. This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Study Details
Timeline
Interventions
Film-coated tablet Oral administration
Film-coated tablet Oral administration
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Solution in prefilled syringe for subcutaneous injection