Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT06609668
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06609668
Study Brief:
Protocol Section:
NCT06609668