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Compares treatment options for Rheumatoid Arthritis (RA
Official title Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07034196
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fulfillment of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis Using these criteria, a classification as "definite RA" is based...
- 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
You likely can't join 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Potsdam, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Potsdam, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.