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

NCT07034196 | Recruiting

• 2 other identifiers: Pro00080017TRMAA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score (DAS-28)

  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.

  6 and 12 month intervals relative to baseline

Study Arms (2)

Control Arm- Rheumatology Clinician

NO INTERVENTION

Continue with usual RA care in their rheumatologist's office

Intervention Arm- Primary Care Clinician

ACTIVE COMPARATOR

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

Other: Primary Care Treatment in lieu of Rheumatologist

Interventions

Primary Care Treatment in lieu of Rheumatologist OTHER

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

Intervention Arm- Primary Care Clinician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
• to 3 small joints (from among the MCP joints, PIP joints, second through fifth MTP joints, thumb IP joints, and wrists) = 2 points
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Lawrence Health System: lead

Study Sites (1)

St. Lawrence Health

Potsdam, New York, 13676, United States

RECRUITING

Related Publications (1)

• Battafarano DF, Ditmyer M, Bolster MB, Fitzgerald JD, Deal C, Bass AR, Molina R, Erickson AR, Hausmann JS, Klein-Gitelman M, Imundo LF, Smith BJ, Jones K, Greene K, Monrad SU. 2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce, 2015-2030. Arthritis Care Res (Hoboken). 2018 Apr;70(4):617-626. doi: 10.1002/acr.23518.

  PMID: 29400009 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eyal Kedar, MD

  St. Lawrence Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

McKailey Lyndaker

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)