Recruiting

Observational StudyComparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial

Sponsor:

St. Lawrence Health System

Code:

NCT07034196

Conditions

Rheumatoid Arthritis (RA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Primary Care Treatment in lieu of Rheumatologist

Study Details

Brief summary:

Rheumatoid arthritis (RA) is a complex autoimmune disease where the immune system attacks healthy joint tissue; causing pain, swelling, and stiffness of the joints. This disease effects lots of people in the US and can lead to major joint damage if not properly treated. In rural areas like northern NY, these are underserved areas for RA patients, thus many patients struggle to get the appropriate care. This model is testing whether primary care providers (PCP) can safely and effectively provide stable RA patients with the proper treatment rather than send them to a specialist. PCPs were trained through classes, case reviews, and a final exam. Patients will be randomly assigned to either see a trained PCP or their normal rheumatologist at the rheumatology clinic. This study will examine how patients are doing over a year using medical exams and patient feedback. If this model proves to be successful, it will make RA treatment easier and more affordable for patients.

Conditions

Rheumatoid Arthritis (RA

Study ID

NCT07034196

Start date

Jun 26, 2025

Status verified date

Jun, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Fulfillment of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis Using these criteria, a classification as "definite RA" is based upon the presence of synovitis in at least one joint, the absence of an alternative diagnosis that better explains the synovitis, and the achievement of a total score of at least 6 (of a possible 10) from the individual scores in four domains.

The highest score achieved in a given domain is used for this calculation. These domains and their values are:

Number and site of involved joints:

2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
1 to 3 small joints (from among the MCP joints, PIP joints, second through fifth MTP joints, thumb IP joints, and wrists) = 2 points
4 to 10 small joints = 3 points
Greater than 10 joints (including at least 1 small joint) = 5 points
Serological abnormality (RF or ACPA)

Low positive (above the upper limit of normal) = 2 points
High positive (greater than three times the upper limit of normal) = 3 points
Elevated acute phase response (ESR or CRP) above the upper limit of normal = 1 point
Symptom duration at least six weeks = 1 point

Stable disease activity, defined as a RAPID-3 score of no higher than 4 over the past three months or no RA-related medication changes for at least six months prior to the informed consent date.
Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties).
Established with the participating rheumatology clinic and a participating PCP (Note: For patients who are established in PCP clinics outside of the health system conducting this study, patients may see a participating PCP within their established clinic). To be considered an established patient, the participant should have had a visit within the year prior to the screening visit.
Willingness to participate in the study and provide informed consent.
Females of childbearing potential must agree to use highly effective birth control throughout duration of the study.

Exclusion Criteria:

Changes in RA treatment within the six months prior to screening.
History of interstitial lung disease or any manifestation of rheumatoid vasculitis including cutaneous rheumatoid vasculitis, vasculitic neuropathy, RA-associated episcleritis, scleritis or keratitis)
Cognitive impairment or inability to complete study assessments.
Pregnancy, breastfeeding, or plans to become pregnant during the study period.
Inability to adhere to the study protocol or follow-up requirements.
Any comorbid condition that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Arm- Rheumatology Clinician

Continue with usual RA care in their rheumatologist's office

active comparator: Intervention Arm- Primary Care Clinician

RA patients will be randomized to receive their RA care via their established PCP who completed a structured training course in RA and who has monthly case review/consultation sessions with the rheumatology team in this study

Interventions

Primary Care Treatment in lieu of Rheumatologist

Primary outcome measure

Change in Disease Activity Score (DAS-28) [ Time Frame: 6 and 12 month intervals relative to baseline ]

Central Contacts and Locations

Central contacts

McKailey Lyndaker

315-261-6352 mckailey.lyndaker@rochesterregional.org

Locations

St. Lawrence Health

Recruiting

Potsdam, New York, United States, 13676

Contacts

McKailey Lyndaker

315-261-6352 mckailey.lyndaker@rochesterregional.org

More Information

Sponsor

St. Lawrence Health System

Last update posted

Jun 24, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by St. Lawrence Health System on 2025-06-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.