Rheumatoid Arthritis Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II
clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of
clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in
subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working
anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be
enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K
will also be evaluated.
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