An observational study in Rheumatoid Arthritis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
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:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 200 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by Rheumatoid Arthritis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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-up
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.
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-up
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-treatment
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.
Plan to share: Undecided — IPD sharing policy not yet defined
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