NCT07632846RecruitingPhase 2
Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 28 May 2026
- Start date
- May 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Horus University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07632846
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From May 2026 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with biological disease modifying antirheumatic drugs.
Other illness
- Patients with renal or hepatic disease.
- Known hypersensitivity to the study medications.
- History of psychiatric disorders.
Lab values
- History of cardiac arrhythmias or prolonged QT interval.
- Use of medications known to prolong the QT interval
Other
- Exclusion Criteria:
- Current use of antioxidant supplements.
- Use of oral prednisolone at a dose greater than 15 mg per day.
- Pregnant or breastfeeding patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Pharmacy, Horus University in Egypt Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.