Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
Study Overview
Brief Summary
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 and outcomes. Treatment modifications, including tapering, discontinuation, and re-treatment, are recorded longitudinally. Participants are followed in the registry from enrollment for up to 60 months, unless a disease flare occurs earlier. Patients experiencing a disease flare within the initial 60-month follow-up period undergo an additional 12 months of follow-up after flare.
The registry aims to provide a comprehensive longitudinal framework of multimodal data to advance the clinical and pathophysiological understanding of remission phenotypes and natural disease trajectories, with the ultimate goals of:
- optimizing risk stratification and therapeutic decision-making in patients with RA in remission; and
- identifying and exploring novel targets for potential transformative therapies.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Antonio Manzo
MD PhD
Fondazione IRCCS Policlinico San Matteo di Pavia