Blood test may detect hidden giant cell arteritis in PMR patients

NCT ID NCT06609668

Diagnosis Sponsor: Centre Hospitalier Universitaire Dijon Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study is testing whether measuring a protein called thrombomodulin in the blood can help rule out giant cell arteritis (GCA) in people with polymyalgia rheumatica (PMR). GCA is a serious inflammation of the arteries that can cause blindness or stroke if not treated. The study will enroll 78 adults over 50 with PMR, take blood samples before treatment, and check thrombomodulin levels. If the test works, it could reduce the need for expensive or invasive tests like ultrasound or biopsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: thrombomodulin blood test
What this could lead to: If successful, this blood test could help doctors quickly identify which PMR patients need further testing for GCA, potentially preventing blindness or stroke.
What could go wrong: This is a small pilot study (78 people) testing a single biomarker. The test may not be accurate enough to replace current imaging or biopsy, and results may not apply to all patients.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Polymyalgia rheumatica (PMR)

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis polymyalgia rheumatica temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell arteritis (GCA) Polymyalgia rheumatica (PMR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Blood test may detect hidden giant cell arteritis in PMR patients

What the study statuses mean