NCT07632846 Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
| NCT ID | NCT07632846 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Horus University |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-05-19 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07632846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07632846 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07632846 currently recruiting?
Yes, NCT07632846 is actively recruiting participants. Contact the research team at amashaly@horus.edu.eg for enrollment information.
Where is the NCT07632846 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07632846 clinical trial?
NCT07632846 is sponsored by Horus University. The trial plans to enroll 50 participants.
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