Actively Recruiting
Pilot Study to Evaluate Thrombomodulin to Rule Out Giant Cell Arteritis in Polymyalgia Rheumatica Patients (THROPIQ)
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-09-09
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Polymyalgia rheumatica (PMR) is a condition affecting people over 50, causing inflammation and pain in the shoulder and hip areas. Sometimes PMR occurs with giant cell arteritis (GCA), a disease affecting large blood vessels, which can cause headaches, vision problems, and other symptoms. GCA can also be present without symptoms, especially when it affects large vessels only. This study aims to find blood markers, specifically thrombomodulin, that can help distinguish between isolated PMR and PMR with GCA, potentially reducing the need for additional imaging or biopsies.
CONDITIONS
Brief Title
Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who has given oral consent
- Patient is 50 years of age or older
- Diagnosed with polymyalgia rheumatica meeting ACR/EULAR 2012 criteria
- Age over 50 at symptom onset
- Inflammatory pain in limb girdles
- Elevated ESR (>20 mm/hr) and/or CRP (>10 mg/L)
- Score of 4 or more points including morning stiffness > 45 minutes, hip pain or limited movement, negative rheumatoid factor or anti-CCP antibodies, and absence of other joint pain
You will not qualify if you...
- Not affiliated with national health insurance
- Under legal protection such as curatorship or guardianship
- Pregnant or breastfeeding
- Unable to provide consent
- Received corticosteroid or immunosuppressive treatment within one month before inclusion
- Contraindication to corticosteroid therapy
- Active infection, cancer, or other inflammatory or autoimmune diseases
- Diagnosed with late onset rheumatoid arthritis
- Conditions preventing vascular imaging such as iodine allergy or severe kidney failure for angio-CT, or uncontrolled diabetes for PET scan
- Final diagnosis of paraneoplastic polymyalgia rheumatica or rheumatoid arthritis
- Negative PET scan if performed after glucocorticoid treatment initiation (within 72 hours)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants provide blood samples before any glucocorticoid or immunosuppressive treatment to measure serum thrombomodulin concentrations and assess for giant cell arteritis.
1 visit (in-person)
Duration - 3 months
Participants provide additional blood samples and are monitored 3 months after inclusion to observe changes and outcomes.
1 follow-up visit (in-person) approximately 3 months after inclusion
Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
A
André RAMON
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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