Roflumilast or desloratadine added to usual RA treatment

Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis

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: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Horus University (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Damietta, Damietta Governorate)
• Trial ID: NCT07566351 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

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 this trial is running

Damietta, Damietta Governorate

• Faculty of Pharmacy, Horus University in Egypt — Damietta, Damietta Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: Amira Mashaly

Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, Roflumilast, Desloratadine, Add-on therapy, double blind Randomized controlled trial