Monitoring remission and planned drug tapering in early rheumatoid arthritis
Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07571993 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pavia, Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.