Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHorus University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with renal or hepatic disease.
Known hypersensitivity to the study medications.
Current use of antioxidant supplements.
History of psychiatric disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Roflumilast 500 Mcg Oral Tablet
DrugRoflumilast 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
DrugMatching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Roflumilast GroupExperimental treatment 1 intervention
Group B: Placebo GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Disease Activity Score (DAS28)
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.
Time frame
12 weeksSecondary outcomes
1
2. Change in serum inflammatory biomarkers
Change in serum levels of inflammatory biomarkers including interleukin-17 (IL-17), monocyte chemoattractant protein-1 (MCP 1), Cyclic adenosine monophosphate (cAMP), and malondialdehyde (MDA).
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov