Evaluating Thrombomodulin for Ruling Out Giant Cell Arteritis in Patients with Polymyalgia Rheumatica

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the use of thrombomodulin as a potential biomarker to rule out giant cell arteritis (GCA) in patients diagnosed with polymyalgia rheumatica (PMR). PMR is a condition characterized by inflammatory pain in older adults, and it can be associated with GCA, which requires more aggressive treatment to prevent serious complications. The study will involve collecting additional blood samples from eligible patients to assess the effectiveness of thrombomodulin in distinguishing between PMR and GCA. The findings could help streamline diagnostic processes and improve patient management.

Why it matters

Who can join: the full rules

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\&#39;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)

Where it's running

• CHU Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: André RAMON
• Email: andre.ramon@chu-dijon.fr
• Phone: 0380293745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.