Actively Recruiting
Rheumatoid Arthritis Remission Screening and Prospective Surveillance
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2026-05-07
200
Participants Needed
1
Research Sites
1304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rheumatoid Arthritis Remission Screening and Prospective Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 or ACR 1987 criteria within 12 months of first evaluation
- Started csDMARD therapy within 12 months of symptom onset
- Continuous csDMARD treatment for at least 24 months
- No previous or current use of biologic or targeted synthetic DMARDs
- DAS28-ESR below 2.6 for at least 6 months without glucocorticoid therapy
- Managed with treatment tapering or discontinuation plan decided with rheumatologist
- Ability to provide written informed consent for registry participation
You will not qualify if you...
- Presence of extra-articular manifestations of rheumatoid arthritis
- Other chronic inflammatory or autoimmune rheumatic diseases besides rheumatoid arthritis
- Personal history of skin or nail psoriasis
- Severe cardiovascular disease
- Severe disability affecting ability to follow protocol or attend visits
- Severe cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
A
Antonio Manzo, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here