RecruitingPhase 2NCT07632846

Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis


Sponsor

Horus University

Enrollment

50 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo Group and a drug called Roflumilast 500 Mcg Oral Tablet for people with rheumatoid arthritis and rheumatoid arthritis (ra). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoflumilast 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.

DRUGPlacebo 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

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NCT07632846


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