Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT03313102
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2017-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of T Lymphocytes in Patients With Horton Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry', 'timeFrame': 'at inclusion'}], 'secondaryOutcomes': [{'measure': 'Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry', 'timeFrame': 'at 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Horton Disease']}, 'descriptionModule': {'briefSummary': 'Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse effects in this elderly population.\n\nCurrently clinicians have no way to estimate this risk of relapse during the treatment of GCA.\n\nInvariant T lymphocytes associated with the mucous membrane (MAIT), whose role in vasculitides has recently been shown and which produce IL-17 and IFN-γ, two key cytokines in the pathophysiology of GCA could be implicated in the pathophysiology of GCA and could constitute a predictive marker of relapse.\n\nOur hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and that the number of circulating MAIT in the blood falls and then returns to normal if the corticoids are effective.\n\nGiven that it will be necessary to include a large number of patients to show that the persistence of a low number of circulating MAIT in patients treated with corticoids is a predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain preliminary data on these new markers.\n\nThe study is classified as interventional because a lot of blood samples are taken'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '51 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPATIENTS\n\n* Patients who have provided written consent\n* Patients with national health insurance cover\n* Age \\> 50 years\n* Patients with Horton disease at the diagnosis, before any treatment.\n\nHorton disease is defined by ACR criteria \\[7\\], the diagnosis is made in the presence of 3 of the following 5 criteria:\n\n* Age at the onset of the disease of 50 years or older\n* Recent-onset localized headache\n* Temporal artery tenderness or decreased temporal artery pulse\n* Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP\\>20 mg/L)\n* Positive temporal artery biopsy (TAB) showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells.\n\nControl groups:\n\nControl Group 1: Healthy subjects Healthy subjects will be matched for age and sex with patients. They will be recruited in Dijon only. They will be healthy volunteers recruited among blood donors, voluntary hospital personnel (nurses, doctors and secretaries) and patients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP\\<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy.\n\nControl Group 2: (PPR without ACG)\n\n* Patient with oral consent\n* Patient affiliated to a social security system\n* Age \\> 50 years old\n* Patient with PPR at diagnosis, before corticosteroid treatment\n* No ACG (see protocol definition)\n\nControl Group 3: (active infection)\n\n* Patient with oral consent\n* Patient affiliated to a social security system\n* Age \\> 50 years old\n* Inflammatory syndrome (CRP \\> 10 mg/L and fibrinogen\\> 4 g/L or CRP \\> 10 mg/L and VS \\> 30 mm/h) explained by a infectious syndrome defined by the association:\n* a fever ≥ 38°C, hypothermia \\< 35°C or fever reported by the patient within 72 hours before inclusion\n* at least 1 associated clinical and/or radiological sign to an organ infection, for example: pneumopathy, urinary infection, bacterial dermohypodermatitis, infection digestive (non-exhasutive list)\n* in the absence of an explanation of the inflammatory syndrome by another cause such as an inflammatory disease or evolutive neoplastic\n\nExclusion Criteria:\n\n* Adults under guardianship\n* Pregnant or breast-feeding women\n* Patients who have been treated with corticosteroids or immunosuppressants in the month preceding inclusion\n* Patients treated with chemotherapy, immunosuppressants or biotherapy\n* Contra-indication for corticosteroid therapy\n* Weight \\<41 kg or Hg \\<7g/l'}, 'identificationModule': {'nctId': 'NCT03313102', 'acronym': 'GAMAIT', 'briefTitle': 'Study of T Lymphocytes in Patients With Horton Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells', 'orgStudyIdInfo': {'id': 'Samson APJ 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Horton disease', 'interventionNames': ['Biological: blood samples']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'interventionNames': ['Biological: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'BIOLOGICAL', 'description': 'sample of 16 blood tubes', 'armGroupLabels': ['Horton disease', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime SAMSON, MD', 'role': 'CONTACT', 'email': 'maxime.samson@chu-dijon.fr', 'phone': '3 80 29 34 32', 'phoneExt': '+33'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Maxime SAMSON, MD', 'role': 'CONTACT', 'email': 'maxime.samson@chu-dijon.fr', 'phone': '3.80.29.34.32', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}