[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643188":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Horus University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Roflumilast Group","EXPERIMENTAL",null,[13],"Drug: Roflumilast 500 Mcg Oral Tablet",{"label":15,"type":10,"description":11,"interventionNames":16},"Placebo Group",[17],"Drug: Placebo Group",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","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.",[9],[25],"Roflumilast",{"type":20,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Amira Mashaly","CONTACT","01028275001","amashaly@horus.edu.eg",[36],{"facility":37,"status":38,"city":39,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Faculty of Pharmacy, Horus University in Egypt","RECRUITING","Al Mansurah","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],31.38069,31.03637,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Amira Fawzy Mohamed Mashaly","Principal Investigator","100643188","phase-2-effect-of-roflumilast-as-add-on-therapy-in-rheumatoid-arthritis-100643188",false,"NCT07632846","Effect of Roflumilast as Add-On Therapy in 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* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\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":64,"type":65},50,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","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.\n\nThe 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.\n\nThe 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.",[71,72],"Rheumatoid Arthritis","Rheumatoid Arthritis (RA)",[25,74,75,76,77],"Rheumatoid arthritis","Randomized controlled trial","Phosphodiesterase-4 inhibitor","Add-on therapy","2026-06-02",{"date":80,"type":81},"2026-06-08","ACTUAL",{"date":83,"type":81},"2026-05-19",{"date":85,"type":65},"2026-12",{"name":5,"class":6},1]