A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.~The study will be conducted in two parts separated by an interim analysis.~Part 1: The subjects will be randomized in a 1:1:1 ratio into: .~AP1189 dose 50 mg~AP1189 dose 100 mg~placebo~INTERIM ANALYSIS~Part 2: All subjects will be randomized into either design 1, 2 or 3 based on data from the interim analysis.~Design 1: AP1189 dose 50 mg or placebo in a 2:1 ratio~Design 2: AP1189 dose 100 mg or placebo in a 2:1 ratio~Design 3: Continue with the same doses as in Part 1~The purpose of this study is to determine the safety and efficacy of 2 doses of AP1189 compared with placebo after 4 weeks of treatment.
This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.