Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
THROPIQ
1 other identifier
observational
78
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
September 9, 2025
September 1, 2025
3 years
September 12, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment)
At baseline
Study Arms (2)
Isolated PMR
2012 PMR classification criteria GCA ACR/EULAR 2022 score \< 6 GCA ACR/EULAR 2022 score: * Shoulder/cervical spine pain/stiffness (+2) * Sudden loss of vision (+3) * Jaw claudication (+2) * Temporal headache (recent) (+2) * Scalp tenderness (+2) * Temporal artery abnormality on clinical examination (+2) * ESR \> 50 mm/h or CRP \> 10 mg/L (+3) * Positive TAB or halo sign (ultrasound) (+5) * Axillary artery involvement (+2) * Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)
PPR associated with GCA
* 2012 PMR classification criteria * ACR/EULAR 2022 score ≥ 6 GCA ACR/EULAR 2022 score: * Shoulder/cervical spine pain/stiffness (+2) * Sudden loss of vision (+3) * Jaw claudication (+2) * Temporal headache (recent) (+2) * Scalp tenderness (+2) * Temporal artery abnormality on clinical examination (+2) * ESR \> 50 mm/h or CRP \> 10 mg/L (+3) * Positive TAB or halo sign (ultrasound) (+5) * Axillary artery involvement (+2) * Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)
Interventions
* 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)
Eligibility Criteria
Polymyalgia rheumatica (PMR)
You may qualify if:
- 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)
You may not qualify if:
- 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 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.
- Final diagnosis of paraneoplastic PMR
- Final diagnosis of RA
- Negative PET scan (if performed 72 hours after glucocorticoid introduction)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21000, France
Biospecimen
Additional blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 24, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
September 9, 2025
Record last verified: 2025-09