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NCT Number: NCT07571993

Rheumatoid Arthritis Remission Screening and Prospective Surveillance

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Synovitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Antonio Manzo, MD PhD

CONTACT

[email protected]

+39 0382 501887

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Longitudinal disease control

    Time frame: From enrollment to 24 months of follow-up

    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

Secondary outcomes

  1. Time-to-flare of rheumatoid arthritis activity

    Time frame: From enrollment up to 60 months of follow-up.

    Predictors of time-to-flare of rheumatoid arthritis activity over up to 60 months of follow-up, including: i) clinical variables, such as clinimetric indices, objective clinical parameters, and patient-reported outcomes; ii) ultrasound-derived variables, such as grey-scale synovitis scores and power Doppler scores; and iii) biological variables, such as phenotypic, molecular, and serological biomarkers.

  2. Longitudinal changes in clinical, ultrasound-derived, and biological variables

    Time frame: From enrollment up to 24 months of follow-up

    Characterization of baseline differences and absolute and relative longitudinal changes in clinical, ultrasound-derived, and biological variables in participants experiencing flare during follow-up (measured from enrollment to flare) and in participants remaining flare-free (measured from enrollment to matched follow-up time points aligned with flare occurrence).

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

    Time frame: At 6 and 12 months after treatment escalation or re-treatment

    Proportion of participants achieving clinical and ultrasound measures comparable to enrollment values at 6 and 12 months following clinically indicated treatment escalation or re-treatment due to arthritis flare.

  4. Comorbidity burden during follow-up

    Time frame: From enrollment up to 60 months of follow-up.

    Longitudinal changes in comorbidity burden (including cardiovascular, metabolic, infectious, neoplastic, and osteoporotic conditions), assessed by the occurrence of newly diagnosed comorbidities and/or changes in standardized comorbidity indices during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Manzo, MD PhD

CONTACT

[email protected]

+39 0382 501887

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)

Acronym: HARMONICS

Important dates

Study start
2022
Primary completion
2047
Study completion
2047
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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