Rheumatoid ArthritisHARMONICSNCT07571993
Rheumatoid Arthritis Remission Screening and Prospective Surveillance
An observational study of Rheumatoid Arthritis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2022to 21 Jun 2047
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by Rheumatoid Arthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Antonio Manzo, MD PhD, +39 0382 501887, a.manzo@smatteo.pv.it
About this study
Official title: Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Clinical remission, Drug-free, Drug-tapering, csDMARDs, Synovitis
- Medical subject headings
- Arthritis, Rheumatoid, Synovitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 24 months of follow-up
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment up to 60 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start21 Jun 2022
- Primary completion21 Jun 2047 (estimated)
- Study completion21 Jun 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Manzo, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Antonio Manzo, MD PhD, Principal investigator, University of Pavia/Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571993
- Sponsor's protocol ID
- HARMONICS
- Acronym
- HARMONICS
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing policy not yet defined
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)
- ClinicalTrials.gov ID
- NCT07571993
- Acronym / sponsor ID
- HARMONICS / HARMONICS
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Clinical remission, Drug-free, Drug-tapering, csDMARDs, Synovitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 21 Jun 2047 (estimated)
- Study completion
- 21 Jun 2047 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Rheumatoid Arthritis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Time-to-flare of rheumatoid arthritis activity
Time frame: From enrollment up to 60 months of follow-up.
Longitudinal changes in clinical, ultrasound-derived, and biological variables
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
Time frame: At 6 and 12 months after treatment escalation or re-treatment
Comorbidity burden during follow-up
Time frame: From enrollment up to 60 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing policy not yet defined
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Manzo, MD PhD principal investigator
University of Pavia/Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Manzo, MD PhD (+39 0382 501887, a.manzo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal disease control (time frame: From enrollment to 24 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.