NCT07571993Recruiting
Rheumatoid Arthritis Remission Screening and Prospective Surveillance
Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 21 Jun 2022
- Primary completion date
- 21 Jun 2047
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07571993
What you commit to
- Study type: Observational
- Planned participants: 200
- From 21 Jun 2022 to the primary completion date, 21 Jun 2047
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant chronic inflammatory or autoimmune rheumatic diseases other than RA
Other illness
- Personal history of cutaneous and/or nail psoriasis
- Severe cardiovascular disease
- Severe cognitive impairment
Other
- Extra-articular manifestations of RA
- Severe functional disability impairing clinical protocol adherence or follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.