Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
Study NCT ID:
NCT06609668
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}, {'id': 'D011111', 'term': 'Polymyalgia Rheumatica'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Additional blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment)', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Giant Cell Arteritis (GCA)', 'Polymyalgia Rheumatica (PMR)']}, 'descriptionModule': {'briefSummary': '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).\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/or temporal artery biopsy and large vessels that relies on PET/FDG 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Polymyalgia rheumatica (PMR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has given oral consent\n* Patient \\> 50 years of age\n\nPatients with PPR, meeting ACR/EULAR 2012 criteria:\n\n* age \\> 50 years at onset of symptoms\n* inflammatory limb-girdle pain\n* elevated ESR (\\>20 mm/hr) and/or CRP (\\> 10 mg/l)\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/autoimmune 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 \\<30 mL/min)\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)'}, 'identificationModule': {'nctId': 'NCT06609668', 'acronym': 'THROPIQ', 'briefTitle': 'Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)', 'orgStudyIdInfo': {'id': 'RAMON AOI 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated PMR', 'description': '2012 PMR classification criteria GCA ACR/EULAR 2022 score \\< 6\n\nGCA ACR/EULAR 2022 score:\n\n* Shoulder/cervical spine pain/stiffness (+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/h or CRP \\> 10 mg/L (+3)\n* Positive TAB or halo sign (ultrasound) (+5)\n* Axillary artery involvement (+2)\n* Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)', 'interventionNames': ['Biological: Additional blood samples']}, {'label': 'PPR associated with GCA', 'description': '* 2012 PMR classification criteria\n* ACR/EULAR 2022 score ≥ 6\n\nGCA ACR/EULAR 2022 score:\n\n* Shoulder/cervical spine pain/stiffness (+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/h or CRP \\> 10 mg/L (+3)\n* Positive TAB or halo sign (ultrasound) (+5)\n* Axillary artery involvement (+2)\n* Aortitis (hypermetabolism of the aorta) on FDG-PET (+2)', 'interventionNames': ['Biological: Additional blood samples']}], 'interventions': [{'name': 'Additional blood samples', 'type': 'BIOLOGICAL', 'description': '* 1 dry tube (5 mL)\n* 1 EDTA tube (6 mL)\n\nPerformed at inclusion (before any glucocorticoid and/or immunosuppressive treatment) and at follow-up visit (3 months after inclusion)', 'armGroupLabels': ['Isolated PMR', 'PPR associated with GCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'André RAMON', 'role': 'CONTACT', 'email': 'andre.ramon@chu-dijon.fr', 'phone': '0380293745'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'André RAMON', 'role': 'CONTACT', 'email': 'andre.ramon@chu-dijon.fr', 'phone': '0380293745'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}