Rheumatoid Arthritis Remission Screening and Prospective Surveillance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed