A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate

Update Il y a 4 ans
Reference: EUCTR2005-006165-14

Woman and Man

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Extract

This is the first study of MLN3897 in any disease population. It seeks to establish: • The ability of MLN3897 to modify the signs and symptoms of rheumatoid arthritis (RA) • The safety and tolerability of MLN3897 in combination with methotrexate (MTX) • The pharmacokinetic (PK)/pharmacodynamic (PD) profile of MLN3897 in the RA population, and comparison to that in the healthy volunteer population with respect to CCR1 receptor blockade • MTX PK and MLN3897 PK and PD when these drugs are used in combination


Inclusion criteria

  • Rheumatoid Arthritis