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Rheumatoid Arthritis Remission Screening and Prospective Surveillance

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Policlinico San Matteo di Pavia
NCT07571993 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

HARMONICS is a prospective registry embedded in the routine clinical practice of the Early Arthritis Clinic and the Prospective Remission Clinic at Fondazione IRCCS Policlinico San Matteo, with an associated research biorepository of voluntarily donated biological samples. It is designed to collect and generate long-term longitudinal data from patients with early-treated rheumatoid arthritis (RA) who have achieved stable clinical remission with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and undergo treatment tapering or discontinuation according to local care pathways, following shared decision-making between the patient and the treating rheumatologist. Following enrollment in stable clinical remission, patients are monitored as part of standard of care at regular intervals using clinical, ultrasound, and radiographic assessments to evaluate disease activity

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📋 Eligibility rules (as published)
Inclusion criteria: * Age ≥18 years * Diagnosis of RA fulfilling the ACR/EULAR 2010 or ACR 1987 classification criteria within 12 months of first evaluation at the Early Arthritis Clinic * Initiation of csDMARD therapy within 12 months of symptom onset * Continuous treatment with csDMARDs for ≥24 months * No prior or current treatment with biologic or targeted synthetic DMARDs * DAS28-ESR \<2.6 for ≥6 months in the absence of glucocorticoid therapy * Management with a treatment tapering or discontinuation strategy with planned monitoring as part of routine clinical care, following shared decision-making with the treating rheumatologist * Ability to provide written informed consent for participation in the registry Exclusion criteria: * Extra-articular manifestations of RA * Concomitant chronic inflammatory or autoimmune rheumatic diseases other than RA * Personal history of cutaneous and/or nail psoriasis * Severe cardiovascular disease * Severe functional disability impairing clinical protocol adherence or follow-up * Severe cognitive impairment
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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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