Rheumatoid Arthritis Remission Screening and Prospective Surveillance

NCT07571993 | Recruiting

• 1 other identifier: HARMONICS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Clinical remission; Drug-free; Drug-tapering; csDMARDs; Synovitis

Outcome Measures

Primary Outcomes (1)

• Longitudinal disease control

  Proportion of participants maintaining longitudinal disease control at 24 months of follow-up, defined as the combined fulfillment of: * absence of clinician-assessed rheumatoid arthritis flare over the 24-month follow-up period; * average annual change in modified Sharp/van der Heijde erosion score (ΔSHSe/year) ≤0.5; and * preserved functional status, defined as HAQ-DI \<0.5 at 24 months

  From enrollment to 24 months of follow-up

Secondary Outcomes (4)

• Time-to-flare of rheumatoid arthritis activity

  From enrollment up to 60 months of follow-up.

• Longitudinal changes in clinical, ultrasound-derived, and biological variables

  From enrollment up to 24 months of follow-up

• Clinical and ultrasound response following treatment escalation or re-treatment due to arthritis flare

  At 6 and 12 months after treatment escalation or re-treatment

• Comorbidity burden during follow-up

  From enrollment up to 60 months of follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by Rheumatoid Arthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells (PBMCs), synovial fluid, synovial tissue, and synovial cells (in participants undergoing minimally invasive joint procedures), as well as RNA extracted from collected samples, for downstream molecular, cellular, and translational analyses.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Synovitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Antonio Manzo, MD PhD

  University of Pavia/Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Manzo, MD PhD

CONTACT

+39 0382 501887; a.manzo@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 7, 2026
• Study Start: June 21, 2022
• Primary Completion (Estimated): June 21, 2047
• Study Completion (Estimated): June 21, 2047
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

IT (1)