Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061
administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with
active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.
To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics
(PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,
based on safety and efficacy, for further clinical development.
Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to participate in an open-label extension (OLE) study ALX0061-C203 (NCT02518620), if the study was approved in their country and selection criteria were met. ;
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