[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Francisco J. Blanco\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645042","medical-device-for-sustained-remission-in-rheumatoid-arthritis-treated-with-biological-therapy-100645042",false,"NCT07678112","Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological Therapy","Efficacy, Safety and Cost-effectiveness of a Biomarker-based Predictive Model for Persistent Remission in Rheumatoid Arthritis Patients Undergoing Biological Therapy Optimization","REMRABIT-Plus","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of rheumatoid arthritis according to either the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR\u002FEULAR classification criteria.\n* Clinical remission for at least 6 months prior to the baseline visit, defined as DAS28-CRP \\\u003C 2.6.\n* Receiving biological anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab, or certolizumab).\n* Ability and willingness to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients in whom biological therapy was prescribed due to systemic manifestations of rheumatoid arthritis.\n* Patients with rheumatoid arthritis and any known associated condition that may interfere with the assessment of study outcomes (e.g., fibromyalgia or concomitant chronic inflammatory diseases).\n* Patients receiving chronic anti-TNF biological therapy who are already undergoing treatment tapering or are on reduced or extended dosing regimens prior to study inclusion.","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate a new tool designed to help doctors decide whether it is safe to reduce medication in patients with rheumatoid arthritis (RA) who are in remission.\n\nRheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing pain, stiffness, and reduced mobility. Many patients receive long-term treatment with biological drugs to control the disease. When the disease is well controlled (remission), doctors may gradually reduce the medication dose. However, deciding when and in whom to reduce treatment is currently based on experience and trial-and-error.\n\nThe study evaluates a predictive tool (called OPTIBIO) that uses information from blood samples, genetic data, and clinical characteristics to estimate the risk that the disease will flare up if treatment is reduced.\n\nParticipants in the study will be randomly assigned to one of two groups:\n\n* In one group, the decision to reduce medication will be made by their usual doctor.\n* In the other group, the decision will be guided by the predictive tool.\n\nThe study lasts 12 months and includes several hospital visits. During these visits, participants will:\n\n* Answer questionnaires about their health and quality of life\n* Have physical examinations\n* Provide blood samples for routine tests and additional research purposes\n* Possibly undergo joint ultrasound (if they consent) Some additional blood samples may be stored in authorized biobanks for future research related to rheumatoid arthritis, but only if participants explicitly agree. These samples will be coded to protect personal identity and will only be used in ethically approved research projects.\n\nParticipation in the study is entirely voluntary. Participants can choose which procedures they agree to and may withdraw at any time without affecting their medical care.\n\nThe study may not provide direct benefit to participants, but it could help improve future treatment decisions and the overall management of rheumatoid arthritis.",[27],"Rheumatoid Arthritis (RA)",[29,30,31,32,33,34],"Rheumatoid arthritis","Treatment Optimization","TNF Inhibitors (TNFi)","Biologic Therapy","Personalized Medicine","Precision Medicine","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-08-28",{"date":43,"type":21},"2027-08",{"name":45,"class":46},"Francisco J. Blanco","OTHER",9,""]