Multiple Sclerosis Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-β) Treatment in Multiple Sclerosis Subjects With Active Disease
The goal of this study was to evaluate the safety, tolerability and effectiveness of oral
cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the
treatment of multiple sclerosis (MS).
This study randomized around 200 participants from approximately 50 sites located world-wide,
who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior
to Screening, irrespective of disability progression. Secondary progressive multiple
sclerosis (SPMS) participants, who were still experiencing relapses, and participants who
have received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS
treatment history, but were currently on IFN-beta therapy and have experienced active MS
symptoms (at least 1 relapse) during the 48 weeks prior to Screening, were enrolled.
Participants were randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or
matching placebo in combination with IFN-beta therapy. Participants who completed the
double-blind portion of the study were invited to participate in an open-label extension
phase of matching study design.
n/a
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