[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556694":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":18,"centralContacts":34,"locations":45,"responsibleParty":177,"collaborators":179,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":18,"enrollmentInfo":192,"targetDuration":18,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm trial","EXPERIMENTAL","Single arm trial in patients with established RA who achieved clinical remission with subcutaneous injection of adalimumab in combination with MTX (methotrexate). Patients will undergo a tapering strategy based only on the clinical status (flare \u002Fno flare) during 12 months.",[13],"Drug: Clinical tapering strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Maintenance arm","NO_INTERVENTION","Maintenance arm: the same adalimumab regimen",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Optimized tapering adalimumab","An optimized tapering adalimumab strategy based on the disease activity and the adalimumab trough concentration. The tapering strategy will rely on the adalimumab trough concentration. Spacing will be performed only if adalimumab trough concentration is above the pre-specified concentration threshold",[23],"Drug: Step Wedge trial",[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":18},"DRUG","Clinical tapering strategy","Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":18},"Step Wedge trial","Step Wedge trial : At baseline, all the patients will receive in this study the standard adalimumab dosing regimen. At subsequent time points (steps), patients will begin the intervention of interest, here the tapering adalimumab strategy. The time at which a patient begins the intervention will be randomized. We fixed the time steps duration to 3 months that corresponds the frequency of there commended follow-up of RA patients",[20],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":18,"email":39},"Hubert MAROTTE, MD PhD","CONTACT","(0)4 77 12 76 49","hubert.marotte@chu-st-etienne.fr",{"name":41,"role":37,"phone":42,"phoneExt":43,"email":44},"Madjid AKROUR","(0)4 77 12 78 37","+33","madjid.akrour@chu-st-etienne.fr",[46,64,78,92,117,133,148,163],{"facility":47,"status":48,"city":49,"state":18,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Infirmerie Protestante","RECRUITING","Caluire-et-Cuire","69300","France","FR",{"type":54,"coordinates":55},"Point",[56,57],4.8464,45.79462,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":18,"email":63},"André BASCH, MD","04 72 00 71 52","andcroco@gmail.com",{"facility":65,"status":48,"city":66,"state":18,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Chd Vendee","La Roche-sur-Yon","85925",{"type":54,"coordinates":69},[70,71],-1.42757,46.66974,{"lat":71,"lon":70},[74],{"name":75,"role":37,"phone":76,"phoneExt":18,"email":77},"Grégoire CORMIER, MD","+33 2 51 44 61 97","gregoire.cormier@ght85.fr",{"facility":79,"status":48,"city":80,"state":18,"zip":81,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Hopital Philibert","Lomme","59160",{"type":54,"coordinates":83},[84,85],2.98715,50.64358,{"lat":85,"lon":84},[88],{"name":89,"role":37,"phone":90,"phoneExt":18,"email":91},"Tristan PASCART, MD PhD","+33 3 20 22 50 59","pascart.tristan@ghicl.net",{"facility":93,"status":48,"city":94,"state":18,"zip":95,"country":51,"countryCode":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Chu Montpellier","Montpellier","34295",{"type":54,"coordinates":97},[98,99],3.87635,43.61093,{"lat":99,"lon":98},[102,106,109,111,113,115],{"name":103,"role":37,"phone":104,"phoneExt":18,"email":105},"Yves-Marie PERS, MD PhD","+33 6 18 99 38 04","ym-pers@chu-montpellier.fr",{"name":107,"role":108,"phone":18,"phoneExt":18,"email":18},"Christian JORGENSEN, MD PhD","SUB_INVESTIGATOR",{"name":110,"role":108,"phone":18,"phoneExt":18,"email":18},"Laurene BERNARD, MD",{"name":112,"role":108,"phone":18,"phoneExt":18,"email":18},"Adriano LERCARA, MD",{"name":114,"role":108,"phone":18,"phoneExt":18,"email":18},"Angélique NALLET, MD",{"name":116,"role":108,"phone":18,"phoneExt":18,"email":18},"Marina THIRION, MD",{"facility":118,"status":48,"city":119,"state":18,"zip":120,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Ap-Hp Pitie Salpetriere","Paris","75013",{"type":54,"coordinates":122},[123,124],2.3488,48.85341,{"lat":124,"lon":123},[127,131],{"name":128,"role":37,"phone":129,"phoneExt":18,"email":130},"Bruno FAUTREL, MD PhD","01 42 17 78 01","bruno.fautrel@aphp.fr",{"name":132,"role":108,"phone":18,"phoneExt":18,"email":18},"Camille FIAUX, MD",{"facility":134,"status":135,"city":136,"state":18,"zip":137,"country":51,"countryCode":52,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Chu Reims","NOT_YET_RECRUITING","Reims","51100",{"type":54,"coordinates":139},[140,141],4.02853,49.26526,{"lat":141,"lon":140},[144],{"name":145,"role":37,"phone":146,"phoneExt":18,"email":147},"Jean-Hugues SALMON, MD PhD","+33 3 26 78 43 73","jhsalmon@chu-reims.fr",{"facility":149,"status":48,"city":150,"state":18,"zip":151,"country":51,"countryCode":52,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Chu Saint Etienne","Saint-Etienne","42055",{"type":54,"coordinates":153},[154,155],4.39,45.43389,{"lat":155,"lon":154},[158,161],{"name":159,"role":37,"phone":160,"phoneExt":43,"email":39},"Hubert MAROTTE, PhD","(0)477127649",{"name":162,"role":37,"phone":42,"phoneExt":43,"email":44},"Madjid Akrour",{"facility":164,"status":135,"city":165,"state":18,"zip":166,"country":51,"countryCode":52,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Chru Tours","Tours","37170",{"type":54,"coordinates":168},[169,170],0.70398,47.39484,{"lat":170,"lon":169},[173],{"name":174,"role":37,"phone":175,"phoneExt":18,"email":176},"Denis MULLEMAN, MD PhD","02 47 47 47 47","denis.mulleman@univ-tours.fr",{"type":178,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[180],{"name":181,"class":182},"AAP MESSIDOR","UNKNOWN","100556694","phase-4-design-and-evaluation-of-an-individualized-biodrug-tapering-strategy-based-on-biodrug-dosage-the-monitora-study-100556694",false,"NCT06528431","Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study","MONITORA","Inclusion Criteria:\n\n* Patient over 18 years of age\n* Patients with a diagnosis of RA according to ACR\u002FEULAR 2010 criteria\n* Remission according to DAS28\\\u003C=2.6 for at least 6 months\n* Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies:\n* ADA 40 mg every two weeks (= every 14 days) according to the standard regimen\n* or ADA 40 mg every 3 weeks (= every 21 days)\n* A negative highly sensitive pregnancy test for women of Childbearing Potential\\*\n* Affiliated person or beneficiary of a social security scheme\n* Informed consent signed by the patient after information\n\nExclusion Criteria:\n\n* Incapacity or refusal to understand and \u002F or sign informed consent to participate in the study.\n* Existing pregnancy, lactation, or intended pregnancy within the next 15 months\n* Fibromyalgia associated to RA\n* Any dose of prednisone for RA treatment 6 months before inclusion\n* Patient deprived of liberty or patient under guardianship or curator ship.","ALL","18 Years",{"count":193,"type":194},180,"ESTIMATED","INTERVENTIONAL",[197],"PHASE4","Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.",[200],"Arthritis, Rheumatoid",[200,202,203,204],"Adalimumab","Remission management","step wedge trial","2025-12-19",{"date":207,"type":208},"2025-12-26","ACTUAL",{"date":210,"type":208},"2024-12-19",{"date":212,"type":194},"2027-12-19",{"name":5,"class":6},8]