Add-on Roflumilast for active rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind, placebo-controlled phase 2 trial, adults with active RA on conventional DMARDs will receive either roflumilast or placebo for about 12 weeks. The goal is to see if roflumilast can further reduce joint swelling and inflammatory markers beyond standard therapy. Safety and tolerability will be monitored throughout the study, along with disease activity scores and patient-reported outcomes. Eligible participants are adults aged 18-60 with active RA who are on methotrexate and do not have major exclusion conditions such as renal/hepatic disease or QT prolongation.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Pharmacy, Horus University in Egypt
  Al Mansurah, Egypt Recruiting

Study contacts

• Study coordinator: Amira Mashaly
• Email: amashaly@horus.edu.eg
• Phone: 01028275001

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.