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NCT Number: NCT06609668

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

additional blood samples

Biological
  • 1 dry tube (5 mL)
  • 1 EDTA tube (6 mL)

Performed at inclusion (before any glucocorticoid and/or immunosuppressive treatment) and at follow-up visit (3 months after inclusion)

Primary outcomes

  1. Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment)

    Time frame: At baseline

Study contacts

Contact information is provided by the study sponsor or research team.

André RAMON

CONTACT

[email protected]

0380293745

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: THROPIQ

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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