[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568924":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":50,"locations":28,"responsibleParty":60,"collaborators":28,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":28,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":28},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"JAK inhibitor dose-tapering strategy","EXPERIMENTAL","The dose-tapering strategy will depend on the JAK inhibitor taken by the patient. It will be based on a 50% dose-reduction every 6 months and will comprise 2 steps:\n\nA. Treatment with baricitinib 4 mg daily:\n\n* Step 1 (after randomization): baricitinib 2mg daily.\n* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): baricitinib 2mg every other day.\n\nB. Treatment with filgotinib 200 mg daily:\n\n* Step 1 (after randomisation): filgotinib 100 mg daily.\n* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): filgotinib 100mg every other day.\n\nC. Treatment with tofacitinib 5 mg twice daily or tofacitinib 11mg daily:\n\n* Step 1 (after randomisation): tofacitinib 5 mg once daily.\n* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): tofacitinib 5 mg every other day.\n\nD. Treatment with upadacitinib 15 mg daily:\n\n• Step 1 (after randomisat",[13,14,15,16],"Drug: Baricitinib (LY3009104) 4 mg","Drug: filgotinib 200mg\u002Fday","Drug: Tofacitinib 5 mg twice daily","Drug: Upadacitinib 15 MG",{"label":18,"type":19,"description":20,"interventionNames":21},"JAK inhibitor continuous therapy strategy","ACTIVE_COMPARATOR","Full dose will be considered in patient taking:\n\n* Baricitinib 4mg\u002Fday\n* Filgotinib: 200mg\u002Fday\n* Tofacitinib : 5mg twice daily or 11mg\u002Fday\n* Upadacitinib: 15mg\u002Fday",[13,14,15,16],[23,29,33,37,41,44,46,48],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Baricitinib (LY3009104) 4 mg","Treatment with baricitinib 4 mg daily\n\n* Step 1 (after randomization): baricitinib 2mg daily\n* Step 2 (in case of CDAI≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): baricitinib 2mg every other day",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"filgotinib 200mg\u002Fday","Treatment with filgotinib 200 mg daily\n\n* Step 1 (after randomisation): filgotinib 100 mg daily\n* Step 2 (in case of CDAI≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): filgotinib 100mg every other day",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Tofacitinib 5 mg twice daily","Treatment with tofacitinib 5 mg twice daily or tofacitinib 11mg daily\n\n* Step 1 (after randomisation): tofacitinib 5 mg once daily\n* Step 2 (in case of CDAI≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): tofacitinib 5 mg every other day",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Upadacitinib 15 MG","Treatment with upadacitinib 15 mg daily\n\n* Step 1 (after randomisation): upadacitinib 15 mg every other day\n* Step 2 (in case of CDAI≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): upadacitinib 15 mg every 4 days",[9],{"type":24,"name":25,"description":42,"armGroupLabels":43,"otherNames":28},"use of JAK inhibitor at full dose until the end of the protocol",[18],{"type":24,"name":30,"description":42,"armGroupLabels":45,"otherNames":28},[18],{"type":24,"name":34,"description":42,"armGroupLabels":47,"otherNames":28},[18],{"type":24,"name":38,"description":42,"armGroupLabels":49,"otherNames":28},[18],[51,56],{"name":52,"role":53,"phone":54,"phoneExt":28,"email":55},"Adeline RUYSSEN-WITRAND, MD","CONTACT","05 61 77 56 26","ruyssen-witrand.a@chu-toulouse.fr",{"name":57,"role":53,"phone":58,"phoneExt":28,"email":59},"Delphine THUILLEZ","(+33 5 61 7)7 69 66","thuillez.d@chu-toulouse.fr",{"type":61,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100568924","phase-4-jak-inhibitor-dose-tapering-strategy-study-100568924",false,"NCT06687551","JAK Inhibitor Dose TAPering Strategy Study","JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients","JAK-TAP","The inclusion criteria will be\n\n1. Aged ≥ 18 years at baseline.\n2. Rheumatoid arthritis defined by the ACR\u002FEULAR criteria.\n3. Treated with a JAK inhibitor, full dose for at least 6 months.\n4. The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.\n5. Being in LDA (CDAI≤10) for at least 6 months.\n6. With a CRP level below the laboratory standard within the month before the inclusion visit.\n7. Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study\n\nThe non-inclusion criteria will be:\n\n1. Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).\n2. Patient with a history of JAK-inhibitor dose reduction\u002Fspacing before enrollment in the study with the JAK-inhibitor currently being taken.\n3. Evidence of flare-up within the last 6 months prior to the inclusion.\n4. Patient who received glucocorticoids \\> 5mg\u002Fday in the 3 months prior the inclusion because of the disease activity of the RA.\n5. Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.\n6. Patient at risk for complication according to the ANSM (60) (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged ≥ 65 years) at baseline AND currently taking baricitinib or filgotinib.\n7. Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12\u002F23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways).\n8. Patient taking immunotherapy for neoplasia.\n9. Surgery scheduled in the next 12 months.\n10. Fibromyalgia according to the physician's opinion.\n11. Anticipated poor compliance with the strategy.\n12. Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.\n13. Alcohol and\u002For drug misuse as determined by the investigator.\n14. Pregnancy or breastfeeding.\n15. Non-affiliation to the French Social Security System.\n16. Patient unwilling to sign the informed consent form.\n17. Patient under legal protection.","ALL","18 Years","65 Years",{"count":74,"type":75},308,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","This study aims to assess the feasibility of tapering JAK inhibitors in rheumatoid arthritis patients in low disease activity by comparing a group of patients tapering the JAK inhibitor dosage to a group of patients continuing the full-dose.\n\nParticipants will:\n\n* Either take\n\n  1. JAK inhibitor dose-tapering strategy.\n  2. JAK inhibitor continuous therapy strategy.\n* Visit the clinic once every 3 months for checkups and tests\n* Keep a diary of their treatment intake and symptoms",[81],"Rhumatoid Arthisis",[83,84,85],"JAK-inhibitor","dose reduction","Rheumatoid arthritis","NOT_YET_RECRUITING","2024-11-12",{"date":89,"type":90},"2024-11-13","ACTUAL",{"date":92,"type":75},"2025-01-01",{"date":94,"type":75},"2029-04-01",{"name":5,"class":6}]