Monitoring remission and planned drug tapering in early rheumatoid arthritis
Official title: Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07571993 · Data updated 2026-11-12
This registry will follow adults with early rheumatoid arthritis who are in stable remission on conventional DMARDs to see if tapering or stopping those drugs is safe and how often disease returns.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | June 21, 2022 |
| Main results expected | June 21, 2047 |
| Study ends | June 21, 2047 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07571993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with early-onset RA treated with csDMARDs within 12 months of symptom onset, on continuous csDMARD therapy for at least 24 months, in DAS28-ESR remission (<2.6) for six months without glucocorticoids, and with no prior biologic or targeted synthetic DMARD exposure.
✕Probably not a fit
Patients with extra-articular RA manifestations, other chronic inflammatory or autoimmune rheumatic diseases, psoriasis, severe cardiovascular disease, major functional disability, prior biologic/targeted therapy, or those not in sustained remission are unlikely to benefit from this registry's tapering-focused approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
HARMONICS is a prospective registry embedded in routine care at the Early Arthritis Clinic and the Prospective Remission Clinic of Fondazione IRCCS Policlinico San Matteo, with an optional biorepository of donated samples. It enrolls patients with early-treated RA who have maintained clinical remission on conventional synthetic DMARDs and who, with their rheumatologist, pursue a planned tapering or discontinuation strategy. Participants are monitored at regular standard-of-care visits with clinical exams, ultrasound, and radiographic assessments, and all treatment modifications including re-treatment are recorded. The registry aims to generate long-term longitudinal clinical and biological data to identify factors linked to sustained drug-free remission or relapse.
Why it matters
Potential benefit: If successful, the registry could help identify which patients can safely reduce or stop csDMARDs, lowering medication burden and side effects.
How similar studies have gone: Previous tapering and discontinuation studies in RA have shown mixed results, with some patients maintaining remission and others relapsing, so the approach has partial but not definitive support.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy Recruiting
Study contacts
- Principal investigator: Antonio Manzo, MD PhD — University of Pavia/Fondazione IRCCS Policlinico San Matteo
- Study coordinator: Antonio Manzo, MD PhD
- Email: a.manzo@smatteo.pv.it
- Phone: +39 0382 501887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.