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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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)

∙ Patient with suspected GCA requiring diagnostic work-up. Suspicion of GCA will be based on:

• The presence of at least one clinical sign of GCA (temporal headache, temporal artery abnormalities, jaw claudication, scalp hyperesthesia, visual disturbance).

• OR the presence of a significant inflammatory syndrome defined by CRP \> 100 mg/L or a ESR \> 100 mm/hr

Locations
Other Locations
France
CHU Dijon Bourgogne
RECRUITING
Dijon
Contact Information
Primary
André RAMON
andre.ramon@chu-dijon.fr
0380293745
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-10
Participants
Target number of participants: 75
Treatments
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)
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov