Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
ConditionRheumatoid 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 disability. Although standard disease-modifying antirheumatic drugs (DMARDs) are effective for many patients, some individuals continue to experience active disease and inflammation. The aim of this study is to evaluate the effectiveness and safety of adding either roflumilast or desloratadine to standard DMARD therapy in patients with rheumatoid arthritis. Participants will be randomly assigned to receive either roflumilast, desloratadine, or placebo in addition to their usual treatment. The study will assess changes in disease activity, inflammatory biomarkers, and patient-reported outcomes over a three-month follow-up period. The results of this study may help identify new add-on treatment options to improve disease control in 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
DrugRoflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs
Desloratadine
DrugDesloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
Placebo
DrugMatching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: RoflumilastExperimental treatment 1 intervention
Group B: DesloratadineExperimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Disease Activity Score (DAS28)
Disease activity will be assessed using the Disease Activity Score in 28 joints (DAS28), which is a composite index ranging from 0 to approximately 9.4. Higher DAS28 scores indicate greater disease activity. The primary outcome is the change in DAS28 score from baseline to 12 weeks.
Time frame
Baseline to 12 weeksSecondary outcomes
1
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
Baseline to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov