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

RecruitingPhase 2Ages 18 Years - 60 YearsAllHorus University
NCT07566351 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Patients receiving methotrexate in addition to standard conventional therapy. Exclusion Criteria: Exclusion Criteria: * Patients with renal or hepatic disease. * Known hypersensitivity to the study medications. * Current use of antioxidant supplements. * History of psychiatric disorders. * Use of oral prednisolone at a dose greater than 15 mg per day. * Current treatment with biological disease modifying antirheumatic drugs. * Pregnant or breastfeeding patients. * History of cardiac arrhythmias or prolonged QT interval. * Use of medications known to prolong the QT interval.
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What it tests

  • Roflumilast
  • Desloratadine
  • Placebo
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Where

1 site
Faculty of Pharmacy, Horus University in Egypt
Damietta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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