Evaluating the Safety and Effectiveness of Oral AP1189 with Methotrexate in Adults with Early Rheumatoid Arthritis Not Previously Treated with DMARDs

What this Trial Is About

Researchers are evaluating the effectiveness and safety of oral AP1189 combined with methotrexate in adults with early rheumatoid arthritis who have not previously been treated with disease-modifying anti-rheumatic drugs DMARDs. This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 40, 70, or 100 mg impact disease activity and inflammation over 12 weeks in participants with active early rheumatoid arthritis. Participants will be randomly assigned to one of four groups, each receiving daily oral treatment for 12 weeks AP1189 at 40 mg, 70 mg, or 100 mg doses alongside methotrexate, or a placebo alongside methotrexate. The study compares the effects of these treatments on rheumatoid arthritis symptoms and inflammation to determine the best dose of AP1189 when combined with methotrexate. During the study, participants will attend scheduled visits for assessments including joint evaluations, blood tests for inflammation markers such as C-reactive protein CRP, and other safety monitoring. Researchers will measure changes in the Disease Activity Score 28 DAS28-CRP at 12 weeks to evaluate treatment impact. Participants will be monitored closely for safety and tolerability throughout the trial period, which lasts about 12 weeks.

A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis