Roflumilast 500 Mcg Oral Tablet: Roflumilast is an oral phosphodiesterase 4 inhibitor administered as add on therapy to standard disease modifying antirheumatic drug treatment. It is used to evaluate its potential anti-inflammatory effects on disease activity and inflammatory markers in patients with active rheumatoid arthritis.
Placebo Group: Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
Study 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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change in Disease Activity Score (DAS28) — 12 weeks Change in disease activity assessed by the Disease Activity Score in 28 joints (DAS28), calculated using tender and swollen joint counts, patient global assessment, and inflammatory markers. DAS28 values are interpreted as follows: remission is defined as a score less than 2.6, low disease activity as 2.6 to 3.2, moderate disease activity as greater than 3.2 to 5.1, and high disease activity as greater than 5.1. The outcome compares DAS28 values at baseline and after 12 weeks of treatment with roflumilast or placebo.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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