A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

Summary

Participation Requirements

Description

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-ti...

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.

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