[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636489":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":31,"studyPopulation":17,"armGroups":32,"interventions":49,"overallOfficials":17,"centralContacts":60,"locations":66,"responsibleParty":80,"collaborators":17,"id":84,"slug":17,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":17,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":69,"whyStopped":17,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Horus University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline to 12 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"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).",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Participants are randomly assigned to one of three parallel groups to receive roflumilast, desloratadine, or placebo in addition to standard therapy.","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"QUADRUPLE","This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.",[27,28,29,30],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic synovial inflammation, progressive joint destruction, and impaired quality of life. Despite the availability of conventional disease-modifying antirheumatic drugs (DMARDs), a subset of patients continues to have persistent disease activity and inflammatory burden.\n\nPhosphodiesterase-4 inhibitors and antihistamines have demonstrated potential anti-inflammatory and immunomodulatory effects that may be beneficial in rheumatoid arthritis. Roflumilast, a selective phosphodiesterase-4 inhibitor, reduces the production of pro-inflammatory cytokines, while desloratadine has been shown to exhibit additional anti-inflammatory properties beyond its antihistaminic effect.\n\nThis randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of roflumilast or desloratadine as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into three parallel groups to receive either roflumilast, desloratadine, or placebo for a duration of three months.\n\nClinical assessments will include evaluation of disease activity scores, inflammatory biomarkers, and patient-reported outcomes. Safety and tolerability will be monitored throughout the study period. The findings of this study may provide evidence for novel adjunctive therapeutic strategies in the management of rheumatoid arthritis.",[33,39,44],{"label":34,"type":35,"description":36,"interventionNames":37},"Roflumilast","EXPERIMENTAL","Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.",[38],"Drug: Roflumilast",{"label":40,"type":35,"description":41,"interventionNames":42},"Desloratadine","Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.",[43],"Drug: Desloratadine",{"label":45,"type":35,"description":46,"interventionNames":47},"Placebo","Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.",[48],"Drug: Placebo",[50,54,57],{"type":51,"name":34,"description":52,"armGroupLabels":53,"otherNames":17},"DRUG","Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs",[34],{"type":51,"name":40,"description":55,"armGroupLabels":56,"otherNames":17},"Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.",[40],{"type":51,"name":45,"description":58,"armGroupLabels":59,"otherNames":17},"Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.",[45],[61],{"name":62,"role":63,"phone":64,"phoneExt":17,"email":65},"Amira Mashaly","CONTACT","01028275001","amashaly@horus.edu.eg",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":17,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":17},"Faculty of Pharmacy, Horus University in Egypt","RECRUITING","Damietta","Damietta Governorate","Egypt","EG",{"type":75,"coordinates":76},"Point",[77,78],31.81332,31.41648,{"lat":78,"lon":77},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Amira Fawzy Mohamed Mashaly","Principal Investigator","100636489",false,"NCT07566351","Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis","Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Disease activity score in 28 joints (DAS28) greater than 2.6.\n* Age between 18 and 60 years.\n* Male and female patients.\n* Patients receiving methotrexate in addition to standard conventional therapy.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Patients with renal or hepatic disease.\n* Known hypersensitivity to the study medications.\n* Current use of antioxidant supplements.\n* History of psychiatric disorders.\n* Use of oral prednisolone at a dose greater than 15 mg per day.\n* Current treatment with biological disease modifying antirheumatic drugs.\n* Pregnant or breastfeeding patients.\n* History of cardiac arrhythmias or prolonged QT interval.\n* Use of medications known to prolong the QT interval.","ALL","18 Years","60 Years",{"count":94,"type":95},90,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","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.",[101],"Rheumatoid Arthritis",[103,34,40,104,105],"Rheumatoid arthritis","Add-on therapy","double blind Randomized controlled trial","2026-05-08",{"date":108,"type":109},"2026-05-12","ACTUAL",{"date":111,"type":109},"2026-04-23",{"date":113,"type":95},"2027-07",{"name":5,"class":6},1]