Roflumilast or desloratadine added to usual RA treatment
Official title: Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis
Run by Horus University · NCT07566351 · Data updated 2026-11-12
This will try adding roflumilast or desloratadine to standard DMARD therapy to see if it reduces inflammation and symptoms in adults 18–60 with active rheumatoid arthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Horus University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Damietta, Damietta Governorate) |
| Status | Recruiting |
| Started | April 23, 2026 |
| Main results expected | June 2027 |
| Study ends | July 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07566351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with active rheumatoid arthritis meeting 2010 ACR/EULAR criteria, a DAS28 > 2.6, currently on methotrexate as part of conventional therapy, and not receiving biologic DMARDs are ideal candidates.
✕Probably not a fit
Patients with significant renal or hepatic disease, pregnant or breastfeeding people, those on biologic DMARDs or QT-prolonging medications, or with relevant psychiatric or cardiac history are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 2 trial that assigns participants to roflumilast, desloratadine, or placebo as add-on therapy to their usual DMARD regimen for three months. Eligible participants are adults 18–60 with active rheumatoid arthritis (DAS28 > 2.6) who are receiving methotrexate and not on biologic DMARDs. The study measures changes in disease activity scores, inflammatory biomarkers, and patient-reported outcomes, with safety and tolerability monitored throughout. The trial is conducted at the Faculty of Pharmacy, Horus University in Damietta, Egypt, with regular clinic visits for assessments during the 3-month follow-up.
Why it matters
Potential benefit: If successful, one of these add-on medications could provide an affordable option to further reduce inflammation and improve symptoms in patients whose RA remains active on standard therapy.
How similar studies have gone: PDE4 inhibitors and some antihistamines have shown anti-inflammatory effects in other conditions, but using roflumilast or desloratadine as add-ons in RA is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion 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. 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.
Where it's running
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Faculty of Pharmacy, Horus University in Egypt
Damietta, Damietta Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Amira Mashaly
- Email: amashaly@horus.edu.eg
- Phone: 01028275001
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.