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Comparing Primary Care and Rheumatologist Care for Rheumatoid Arthritis

This study is looking at whether primary care providers (PCPs) who have been specially trained can effectively manage rheumatoid arthritis (RA) in patients. RA is a condition where your immune system attacks your joints, causing pain and swelling. In many rural areas, it's hard to see a rheumatologist (a doctor specializing in joint diseases). This trial will randomly assign 100 RA patients to either receive care from their established PCP (who has completed special training and has monthly consultations with rheumatology experts) or continue with their usual rheumatologist care. The main goal is to see if there's a difference in your disease activity (measured by DAS-28 scores) after 6 and 12 months. To join, you must be at least 18 years old and meet the specific criteria for definite RA.

Study design
This is an interventional study that will randomly assign 100 participants to one of two care groups. The study does not specify a phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with disease activity measured at 6 and 12 months after starting the study.

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NCT07034196

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

Recruiting
NAAges 18+InterventionalTreatment
St. Lawrence Health System
~100 participants
Updated 2025-06-24 on ClinicalTrials.gov
What's tested:Primary Care Treatment in lieu of Rheumatologist

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Disease Activity Score (DAS-28)
Measured over 6 and 12 month intervals relative to baseline

Conditions

Rheumatoid Arthritis (RA

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Eyal Kedar, MD · PRINCIPAL_INVESTIGATOR · St. Lawrence Health

Who to contact

McKailey Lyndaker
[email protected]
315-261-6352
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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Change in Disease Activity Score (DAS-28)6 and 12 month intervals relative to baseline

    The primary efficacy endpoint is the change in Disease Activity Score (DAS-28) response at 6 and 12 month intervals relative to baseline. It will be evaluated for non-inferiority of the treatment effect. The treatment difference between the Primary Care group and the Rheumatology group may be presented with point estimate and 95% CI.