[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562938":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Dijon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Isolated PMR",null,"2012 PMR classification criteria GCA ACR\u002FEULAR 2022 score \\\u003C 6\n\nGCA ACR\u002FEULAR 2022 score:\n\n* Shoulder\u002Fcervical spine pain\u002Fstiffness (+2)\n* Sudden loss of vision (+3)\n* Jaw claudication (+2)\n* Temporal headache (recent) (+2)\n* Scalp tenderness (+2)\n* Temporal artery abnormality on clinical examination (+2)\n* ESR \\> 50 mm\u002Fh or CRP \\> 10 mg\u002FL (+3)\n* Positive TAB or halo sign (ultrasound) (+5)\n* Axillary artery involvement (+2)\n* Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)",[13],"Biological: Additional blood samples",{"label":15,"type":10,"description":16,"interventionNames":17},"PPR associated with GCA","* 2012 PMR classification criteria\n* ACR\u002FEULAR 2022 score ≥ 6\n\nGCA ACR\u002FEULAR 2022 score:\n\n* Shoulder\u002Fcervical spine pain\u002Fstiffness (+2)\n* Sudden loss of vision (+3)\n* Jaw claudication (+2)\n* Temporal headache (recent) (+2)\n* Scalp tenderness (+2)\n* Temporal artery abnormality on clinical examination (+2)\n* ESR \\> 50 mm\u002Fh or CRP \\> 10 mg\u002FL (+3)\n* Positive TAB or halo sign (ultrasound) (+5)\n* Axillary artery involvement (+2)\n* Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BIOLOGICAL","Additional blood samples","* 1 dry tube (5 mL)\n* 1 EDTA tube (6 mL)\n\nPerformed at inclusion (before any glucocorticoid and\u002For immunosuppressive treatment) and at follow-up visit (3 months after inclusion)",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"André RAMON","CONTACT","0380293745","andre.ramon@chu-dijon.fr",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"CHU Dijon Bourgogne","RECRUITING","Dijon","21000","France","FR",{"type":39,"coordinates":40},"Point",[41,42],5.01391,47.31344,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100562938","pilot-study-to-evaluatethrombomodulin-to-rule-out-giant-cell-arteritis-gca-in-polymyalgia-rheumatica-pmr-patients-thropiq-100562938",false,"NCT06609668","Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)","THROPIQ","Inclusion Criteria:\n\n* Patient who has given oral consent\n* Patient \\> 50 years of age\n\nPatients with PPR, meeting ACR\u002FEULAR 2012 criteria:\n\n* age \\> 50 years at onset of symptoms\n* inflammatory limb-girdle pain\n* elevated ESR (\\>20 mm\u002Fhr) and\u002For CRP (\\> 10 mg\u002Fl)\n* AND Score ≥ 4 points among\n\n  * Morning stiffness \\> 45 minutes (2 pts)\n  * Hip pain or limitation of amplitude (1 pt)\n  * Rheumatoid factor or anti-CCP antibodies negative (2 pts)\n  * Absence of other joint pain (1 pt)\n\nExclusion Criteria:\n\n* Patient not affiliated to national health insurance\n* Patient under legal protection (curatorship, guardianship)\n* Patient subject to a measure of legal safeguard\n* Pregnant or breast-feeding women\n* Adult patient unable to provide consent\n* Patient having received corticosteroid or immunosuppressive treatment in the month prior to inclusion\n* Patient with a contraindication to corticosteroid therapy\n* Patients with an active infection, neoplasia or other inflammatory\u002Fautoimmune condition\n* Patients with late onset rheumatoid arthritis.\n* Conditions rendering vascular imaging unfeasible or uninterpretable:\n* For angio-CT: allergy to iodine, renal failure (CKD \\\u003C30 mL\u002Fmin)\n* 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.\n\nSecondary exclusion criteria:\n\n* Final diagnosis of paraneoplastic PMR\n* Final diagnosis of RA\n* Negative PET scan (if performed 72 hours after glucocorticoid introduction)","ALL","50 Years",{"count":58,"type":59},78,"ESTIMATED","OBSERVATIONAL","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\u002For ESR. However, GCA could be asymptomatic in particular in case of isolated involvement of large vessels (subclinical GCA).\n\nGCA 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\u002For temporal artery biopsy and large vessels that relies on PET\u002FFDG or angio CT scan.\n\nThe 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.",[63,64],"Giant Cell Arteritis (GCA)","Polymyalgia Rheumatica (PMR)","2025-09-02",{"date":67,"type":68},"2025-09-09","ACTUAL",{"date":70,"type":68},"2024-10-10",{"date":72,"type":59},"2027-10",{"name":5,"class":6},1]