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

Condition(s) studied

Investigational drug(s) / intervention(s)

Roflumilast: Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs

Desloratadine: Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

Placebo: Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

Study summary

Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and disability. Although standard disease-modifying antirheumatic drugs (DMARDs) are effective for many patients, some individuals continue to experience active disease and inflammation. The aim of this study is to evaluate the effectiveness and safety of adding either roflumilast or desloratadine to standard DMARD therapy in patients with rheumatoid arthritis. Participants will be randomly assigned to receive either roflumilast, desloratadine, or placebo in addition to their usual treatment. The study will assess changes in disease activity, inflammatory biomarkers, and patient-reported outcomes over a three-month follow-up period. The results of this study may help identify new add-on treatment options to improve disease control in patients with rheumatoid arthritis.

Eligibility

Primary outcome measure(s)

• Change in Disease Activity Score (DAS28) — Baseline to 12 weeks
  Disease activity will be assessed using the Disease Activity Score in 28 joints (DAS28), which is a composite index ranging from 0 to approximately 9.4. Higher DAS28 scores indicate greater disease activity. The primary outcome is the change in DAS28 score from baseline to 12 weeks.

Trial sites (1)

More Horus University trials in Egypt

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