Rheumatoid Arthritis Remission Screening and Prospective Surveillance
ConditionRheumatoid Arthritis
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients affected by Rheumatoid Arthritis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
From enrollment to 24 months of follow-upSecondary outcomes
1
Time-to-flare of rheumatoid arthritis activity
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.
Time frame
From enrollment up to 60 months of follow-up.2
Longitudinal changes in clinical, ultrasound-derived, and biological variables
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).
Time frame
From enrollment up to 24 months of follow-up3
Clinical and ultrasound response following treatment escalation or re-treatment due to arthritis flare
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.
Time frame
At 6 and 12 months after treatment escalation or re-treatment4
Comorbidity burden during 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.
Time frame
From enrollment up to 60 months of follow-up.Sponsors and contacts
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Source ClinicalTrials.gov