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Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

RecruitingPhase 2

Sponsor: Horus University

Conditions: Rheumatoid Arthritis, Rheumatoid Arthritis (RA)

Interventions: Roflumilast 500 Mcg Oral Tablet, Placebo Group

Countries: Egypt

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.
* Ability to provide written informed consent.

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

Locations (1)

Al Mansurah, Egypt