Status:
RECRUITING
Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Giant Cell Arteritis (GCA)
Polymyalgia Rheumatica (PMR)
Eligibility:
All Genders
50+ years
Brief Summary
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 oft...
Eligibility Criteria
Inclusion
- Patient who has given oral consent
- Patient \> 50 years of age
- Patients with PPR, meeting ACR/EULAR 2012 criteria:
- age \> 50 years at onset of symptoms
- inflammatory limb-girdle pain
- elevated ESR (\>20 mm/hr) and/or CRP (\> 10 mg/l)
- AND Score ≥ 4 points among
- Morning stiffness \> 45 minutes (2 pts)
- Hip pain or limitation of amplitude (1 pt)
- Rheumatoid factor or anti-CCP antibodies negative (2 pts)
- Absence of other joint pain (1 pt)
Exclusion
- Patient not affiliated to national health insurance
- Patient under legal protection (curatorship, guardianship)
- Patient subject to a measure of legal safeguard
- Pregnant or breast-feeding women
- Adult patient unable to provide consent
- Patient having received corticosteroid or immunosuppressive treatment in the month prior to inclusion
- Patient with a contraindication to corticosteroid therapy
- Patients with an active infection, neoplasia or other inflammatory/autoimmune condition
- Patients with late onset rheumatoid arthritis.
- Conditions rendering vascular imaging unfeasible or uninterpretable:
- For angio-CT: allergy to iodine, renal failure (CKD \<30 mL/min)
- For PET scan: unbalanced diabetes NB: only one of the two vascular imaging techniques will be performed, depending on the patient\'s condition and the technical resources available.
- Secondary exclusion criteria:
- Final diagnosis of paraneoplastic PMR
- Final diagnosis of RA
- Negative PET scan (if performed 72 hours after glucocorticoid introduction)
Key Trial Info
Start Date :
October 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06609668
Start Date
October 10 2024
End Date
October 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
CHU Dijon Bourgogne
Dijon, France, 21000