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

Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)

This study is testing if a blood marker called thrombomodulin can help doctors tell if older patients with polymyalgia rheumatica also have giant cell arteritis.

Quick facts

• Study type: Observational
• Enrollment: 78 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (other)
• Locations: 1 site (Dijon)
• Trial ID: NCT06609668 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients over 50 years old with a diagnosis of polymyalgia rheumatica and suspected giant cell arteritis.

Not a fit: Patients who do not have polymyalgia rheumatica or those without any suspicion of giant cell arteritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses for patients with PMR, potentially reducing unnecessary treatments and complications associated with GCA.

How similar studies have performed: While the specific use of thrombomodulin in this context may be novel, similar studies exploring biomarkers for diagnosing GCA in PMR patients have shown promise.

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\&#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 this trial is running

Dijon

• CHU Dijon Bourgogne — Dijon, France (RECRUITING)

Study contacts

• Study coordinator: André RAMON

Conditions: Giant Cell Arteritis, Polymyalgia Rheumatica