Rheumatoid Arthritis Clinical Trial
Official title:
A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
The study is designed to explore whether F8IL10 can be safely administered in combination
with standard-dose of MTX in patients with active rheumatoid arthritis and to determine the
recommended dose of F8IL10 when combined with MTX.
As soon as the MTD/RD is determined, an additional 12 patients will be randomized (6+6)
between F8IL10 (RD) and placebo to further investigate the safety and pharmacacodynamics
profile of the study treatment.
Methotrexate (MTX) will be administered as concomitant medication in the dose escalation as
well as in the randomized part of the study.
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