Actively Recruiting
Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
Led by Horus University · Updated on 2026-05-12
90
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Faculty of Pharmacy, Horus University in Egypt
Damietta, Damietta Governorate, Egypt
Actively Recruiting
Research Team
A
Amira Mashaly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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