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Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
Sponsor: Horus University
Summary
Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease. The purpose of this study is to evaluate the effectiveness and safety of adding roflumilast to standard therapy in patients with active rheumatoid arthritis. Participants will receive either roflumilast or placebo in addition to their usual treatment. The study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether roflumilast could be a useful add-on treatment option for patients with rheumatoid arthritis.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-05-19
Completion Date
2026-12
Last Updated
2026-06-08
Healthy Volunteers
No
Interventions
Roflumilast 500 Mcg Oral Tablet
Roflumilast is an oral phosphodiesterase 4 inhibitor administered as add on therapy to standard disease modifying antirheumatic drug treatment. It is used to evaluate its potential anti-inflammatory effects on disease activity and inflammatory markers in patients with active rheumatoid arthritis.
Placebo Group
Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
Locations (1)
Faculty of Pharmacy, Horus University in Egypt
Al Mansurah, Egypt