Actively Recruiting

Age: 18Years +
All Genders
NCT07571993

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy, 27100

Actively Recruiting

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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

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