Study to Evaluate Roflumilast and Desloratadine Added to Standard Treatment for Rheumatoid Arthritis in Adults

What this Trial Is About

Rheumatoid arthritis is a chronic autoimmune disease causing joint pain, swelling, and disability despite treatment with standard disease-modifying antirheumatic drugs DMARDs. Researchers are evaluating whether adding roflumilast or desloratadine to standard DMARD therapy can better control disease activity and inflammation in patients with persistent symptoms. This phase 2 randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of these add-on treatments for rheumatoid arthritis over a three-month period. Participants will be randomly assigned to one of three groups receiving roflumilast, desloratadine, or placebo, each added to their usual DMARD therapy. Treatments are given orally and continue for three months. The studys design includes parallel groups to compare each add-on treatment against placebo while patients maintain their standard care. During the study, participants will undergo clinical assessments including disease activity scoring DAS28, blood tests to measure inflammatory markers, and patient-reported outcome questionnaires. Safety and tolerability will be monitored throughout the 12-week treatment. Researchers will track changes from baseline to 12 weeks to determine the impact of the treatments. Participation lasts about three months, with regular evaluations to monitor progress and safety.

Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis