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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHorus University

About this trial

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 criteria

Qualifiers

Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.

Disease activity score in 28 joints (DAS28) greater than 2.6.

Age between 18 and 60 years.

Male and female patients.

Disqualifiers

Patients with renal or hepatic disease.

Known hypersensitivity to the study medications.

Current use of antioxidant supplements.

History of psychiatric disorders.

Trial design

Treatments tested in this trial

  • Roflumilast
  • Desloratadine
  • Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators