Rheumatoid Arthritis Remission Screening and Prospective... | NCT07571993

Studies
Rheumatoid Arthritis Remission Screening and Prospective Surveillance

NCT07571993

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2022Actual

Primary Completion Date

Jun 21, 2047Estimated

Completion Date

Jun 21, 2047Estimated

First Submitted Date

Apr 22, 2026

First Submission Date that Met QC Criteria

Apr 30, 2026

First Posted Date

May 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

60 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	From enrollment to 24 months of follow-up

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients affected by Rheumatoid Arthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Manzo, MD PhD	Contact	+39 0382 501887		a.manzo@smatteo.pv.it

Overall Officials

Name	Affiliation	Role
Antonio Manzo, MD PhD	University of Pavia/Fondazione IRCCS Policlinico San Matteo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Policlinico San Matteo	Recruiting	Pavia	Pavia	27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD sharing policy not yet defined

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D013585	Synovitis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Serum, peripheral blood mononuclear cells (PBMCs), synovial fluid, synovial tissue, and synovial cells (in participants undergoing minimally invasive joint procedures), as well as RNA extracted from collected samples, for downstream molecular, cellular, and translational analyses.