Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
The primary objective of this study is:
- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered
subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
The secondary objectives of this study are:
- To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose
regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical
development.
- To obtain parallel descriptive information concerning the efficacy and safety of
tocilizumab (TCZ) s.c. in the same clinical trial RA population.
n/a
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