Actively Recruiting
Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-09-09
78
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polymyalgia rheumatica (PMR) is a rheumatologic condition occurring in patients \> 50 years old, characterized by inflammatory pain of the scapular (shoulder) and pelvic (hip) girdles. PMR is most often isolated but can be associated with giant cell arteritis (GCA), a large vessels vasculitis, in 16 to 21% of case. The main features of GCA are headaches, jaw claudication, visual disturbances, abnormal temporal artery, scalp tenderness associated to elevated CRP and/or ESR. However, GCA could be asymptomatic in particular in case of isolated involvement of large vessels (subclinical GCA). GCA requires high doses of glucocorticoids, compared to isolated PMR, to avoid complications resulting from vascular remodeling (stroke, blindness). Ruling out GCA in PMR patients relies on the performance of some complementary exams that explore cranial vessels as color doppler ultrasound and/or temporal artery biopsy and large vessels that relies on PET/FDG or angio CT scan. The aim of this study is to identifie serum biomarkers that could rule out or identifies GCA in patients with PMR features. Ultimately, if biomarkers are identified, this could allow to select PMR patients in whom complementary exams are needed or not. For this study, investigators chose to explore thrombomodulin. Thrombomodulin is a protein that is increased in the circulating blood during vascular inflammation, and therefore seems to be a good candidate for distinguish isolated PMR from PMR associated with GCA.
CONDITIONS
Official 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 over 50 years of age
- Diagnosed with polymyalgia rheumatica (PMR) meeting ACR/EULAR 2012 criteria
- Age over 50 years at symptom onset
- Inflammatory pain in shoulder and hip areas
- Elevated ESR (>20 mm/hr) and/or CRP (>10 mg/l)
- Score of 4 or more points based on 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 (curatorship or guardianship)
- Subject to a legal safeguard measure
- Pregnant or breastfeeding
- Unable to provide consent
- Received corticosteroid or immunosuppressive treatment in the month before inclusion
- Contraindication to corticosteroid therapy
- Active infection, cancer, or other inflammatory/autoimmune diseases
- Late onset rheumatoid arthritis
- Conditions preventing vascular imaging, such as iodine allergy or severe kidney failure for angio-CT, or unbalanced diabetes for PET scan
- Final diagnosis of paraneoplastic PMR or rheumatoid arthritis
- Negative PET scan if done after glucocorticoid treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
A
André RAMON
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here