Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHorus University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patients with renal or hepatic disease.
Known hypersensitivity to the study medications.
Current use of antioxidant supplements.
History of psychiatric disorders.
Trial design
Treatments tested in this trial
- Roflumilast 500 Mcg Oral Tablet
- Placebo Group
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
1Faculty of Pharmacy, Horus University in Egypt Al Mansurah Egypt
Sponsors and collaborators
Horus University
Lead sponsor
Source ClinicalTrials.gov