Giant Cell Arteritis (GCA)THROPIQNCT06609668
Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
An observational study of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA), Polymyalgia Rheumatica (PMR)
- What is being tested?
- Additional blood samples
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Polymyalgia rheumatica (PMR)
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
André RAMON, 0380293745, andre.ramon@chu-dijon.fr
About this study
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.
- Being tested
- Additional blood samples
- Medical subject headings
- Giant Cell Arteritis, Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplesBiological
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Additional blood samples | |
| 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) Receives: Biological: Additional blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start10 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609668
- Sponsor's protocol ID
- RAMON AOI 2022
- Acronym
- THROPIQ
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
- ClinicalTrials.gov ID
- NCT06609668
- Acronym / sponsor ID
- THROPIQ / RAMON AOI 2022
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated PMR | – | Biological: Additional blood samples2012 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 | – | Biological: Additional blood samples* 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Polymyalgia rheumatica (PMR)
Key inclusion criteria (11 listed)
- Patient who has given oral consent
- Patient > 50 years of age
- age > 50 years at onset of symptoms
- inflammatory limb-girdle pain
- elevated ESR (>20 mm/hr) and/or CRP (> 10 mg/l)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood samples* 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) | Biological | Isolated PMR, PPR associated with GCA |
Primary outcome
Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact André RAMON (0380293745, andre.ramon@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment) (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.