[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"giant-cell-arteritis-gca\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:giant-cell-arteritis-gca":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,44,74,103,129,156,179,204,232,258,284,311,338,362,381,412,439,463,497,525,551],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100613695","mapping-b-cell-biology-across-the-cardiovascular-territories-of-giant-cell-arteritis-towards-a-new-therapeutic-approach-rituximap-gca-100613695",false,"NCT07269938","Mapping B-cell Biology Across the Cardiovascular Territories of Giant Cell Arteritis: Towards a New Therapeutic Approach (RituxiMAP GCA)","RituxiMAP GCA","Inclusion Criteria:\n\n* For GCA group:\n\n  1. Adults ≥ 50 years at the time of enrolment\n  2. Meets 2022 American College of Rheumatology\u002FEULAR classification criteria for giant cell arteritis\n  3. Imaging evidence of active LV-GCA in the previous 4 weeks\n  4. Will be managed with corticosteroid monotherapy by the standard care team.\n\nFor BCMID group:\n\n1. Adults ≥ 18 years at the time of enrolment\n2. Meets criteria for a diagnosis of a B-cell mediated immune disorder\n3. Considered to have active disease by referring team\n4. Will be managed as per standard of care by referring team\n\nFor AA group:\n\n1. Adults ≥ 50 years at the time of enrolment\n2. Imaging evidence of atherosclerotic aortic aneurysm\n\nExclusion Criteria:\n\n1. Participants receiving corticosteroids for \\>4 weeks immediately prior to baseline\n2. Previous diagnosis of GCA\n3. History of any major morbidity which the clinical investigator considers contraindicated to study entry\n4. Pregnancy or breastfeeding\n5. Advanced renal dysfunction (eGFR \\\u003C15ml\u002Fmin\u002F1.73m2)\n6. Patients without mental capacity or willingness to provide informed consent\n7. Inability or unwillingness to comply with the radiation protection advice",true,"ALL","50 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","B cells are a component of the immune system which appear be important in causing all forms of cardiovascular disease. Until now, it has not been possible to directly study these cells in living patients (essential to assess their potential as the target of new treatments). For the first time in any cardiovascular disease, this study will apply cutting edge scanning technology to visualise B cells in the blood vessels of giant cell arteritis (GCA) patients. GCA is a common and potentially deadly disorder of the blood vessels which is caused by abnormalities of the immune system. Current treatments are mainly limited to steroids. Unfortunately, these drugs bring tremendous side effects and so there is an urgent requirement to discover alternatives.\n\nLaboratory investigations tell us that B cells are highly present in GCA and so if the proposed scanning technology fails to identify these cells in the blood vessels of participants, then the technology is unlikely to be useful for other cardiovascular diseases. If, however, the study does successfully visualise B cells, this knowledge could pave the way for clinical trials of B cell targeted treatments (already established in other conditions) as steroid alternatives in GCA.\n\nThis study aims to map the distribution of the radiotracer zirconium-89 labelled rituximab within the blood vessels of patients with newly diagnosed GCA and compare this with two separate control groups without the condition. This will allow us to determine the role of B cells within this condition, and whether patients would benefit from B cell-depleting treatments such as rituximab.",[25],"Giant Cell Arteritis (GCA)",[27,28,29,30],"Giant cell arteritis","Vasculitis","Rituximab","PET scanning","NOT_YET_RECRUITING","2026-06-12",{"date":34,"type":35},"2026-06-16","ACTUAL",{"date":37,"type":21},"2026-10",{"date":39,"type":21},"2029-06",{"name":41,"class":42},"University of Edinburgh","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100601276","phase-2-tocilizumab-discontinuation-versus-dose-reduction-for-patients-with-well-controlled-giant-cell-arteritis-100601276","NCT07108387","Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis","A Randomized Study of Tocilizumab Discontinuation for Patients With Giant Cell Arteritis in Remission (AGA01)","Inclusion Criteria:\n\n1. Ability and willingness to provide written informed consent and to comply with the study protocol\n2. Diagnosis of Giant cell arteritis (GCA) classified according to the following criteria:\n\n   a. AND at least one of the following:\n\n   i. Cranial signs or symptoms of GCA (new-onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)\n\n   ii. Symptoms of polymyalgia rheumatica (PMR), defined as shoulder and \u002F or hip girdle pain associated with inflammatory morning stiffness\n\n   b. AND at least one of the following:\n\n   i. Artery biopsy revealing features of GCA (e.g., mononuclear cell infiltration or granulomatous inflammation)\n\n   ii. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as ultrasound (US), Magnetic resonance angiography (MRA), computerized tomography angiography (CTA), or Positron emission tomography-computerized tomography (PET-CT)\n\n   iii. Ultrasound (US) or Magnetic resonance imaging (MRI) or PET\u002FCT demonstration of features of GCA in a cranial artery\n3. Glucocorticoid-free remission on Tacrolimus (TCZ) therapy according to the following criteria:\n\n   1. Ongoing treatment with TCZ (ACTEMRA(R) or one of its FDA-approved biosimilars) administered at 6-8 mg\u002Fkg IV every 4 weeks OR 162 mg subcutaneous (SC) weekly for at least 12 months prior to randomization. Participants cannot have missed more than one SC dose or any Intravenously (IV) doses in the 2 months prior to randomization\n   2. Disease remission for at least 12 months prior to randomization defined as the absence of clinical signs or symptoms of active GCA and Polymyalgia rheumatica (PMR) along with normal values of C-reactive protein (CRP) (\\\u003C 10 mg\u002FL) at screening\n   3. Absence of oral, IV, intramuscular (IM), or SC glucocorticoid treatment for at least 3 months prior to randomization\n\nExclusion Criteria:\n\n1. An autoimmune disease or other condition, other than Giant cell arteritis (GCA), that requires\u002Fis anticipated to require chronic or recurrent oral or parenteral glucocorticoids or other immunomodulatory therapy. (Topical and inhaled therapies are acceptable)\n2. Hospitalization within 8 weeks prior to randomization\n3. Suspected or established adrenal insufficiency\n4. Treatment with any investigational agent within 12 months of randomization\n5. Concomitant treatment with another biologic immunosuppressant (e.g., etanercept, adalimumab, infliximab, certolizumab, golimumab, sarilumab, abatacept, rituximab, or secukinumab) within 12 months prior to randomization. Concomitant treatment with non-biologic immunosuppressants (e.g.\n\n   JAK inhibitors, Methotrexate (MTX)) within 3 months prior to randomization. An exception is hydroxychloroquine, which is permitted as long as the dose has been stable for the 8 weeks preceding randomization\n6. Immunization with a live\u002Fattenuated vaccine within \\\u003C= 4 weeks prior to randomization\n7. History of severe allergic or anaphylactic reactions to Tocilizumab (TCZ) or to prednisone (or equivalent)\n8. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis\u002Fosteomalacia, glaucoma, corneal ulcers\u002Finjuries, or gastrointestinal (GI) disease\n9. Serologic evidence of chronic hepatitis infection at time of TCZ initiation or at screening if not previously assessed:\n\n   1. Evidence of current or prior infection with hepatitis B, as indicated by a positive test for the hepatitis B surface antigen or an isolated positive test for the hepatitis B core antibody. If a participant has an isolated positive hepatitis B core antibody, clearance after consultation with infectious disease specialist or gastroenterologist\u002Fhepatologist must be obtained\n   2. Evidence of current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response \\>= 12 weeks. If a participant has a positive or indeterminate hepatitis C antibody, viral load testing (e.g., reflex testing) is required. Clearance after consultation with infectious disease specialist or gastroenterologist\u002Fhepatologist must be obtained\n10. Positive interferon gamma release assay (IGRA) (e.g., QuantiFERON Gold or equivalent) at time of TCZ initiation or at screening if not previously assessed\n\n    1. If the participant has had the BCG vaccine or has some other condition complicating the interpretation of tuberculosis (TB) testing, clearance after consultation with infectious disease specialist or pulmonologist must be obtained\n    2. Participants diagnosed with latent TB are eligible but must have initiated appropriate prophylaxis for at least 30 days prior to initiation of study treatment\n    3. Indeterminate IGRA must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the IGRA remains indeterminate, a participant must have a negative tuberculin purified protein derivative skin test (PPD) or clearance after consultation with infectious disease specialist or pulmonologist.\n11. Known active bacterial, viral, fungal, mycobacterial, or other infections except fungal infections of the nail beds and superficial cutaneous infection treated topically\n12. Participant is pregnant or breastfeeding or planning a pregnancy while enrolled in the study\n13. Any infection requiring treatment with IV antibiotics within 4 weeks of randomization or oral antibiotics within 2 weeks of randomization\n14. Active treatment for malignancy at the time of randomization, with exception of prophylactic hormonal therapy (e.g. prostate cancer, breast cancer, etc.)\n15. History of alcohol, drug, or chemical abuse within 12 months prior to randomization\n16. History of chronic or recurrent infection (excluding simple cystitis, viral respiratory infection, sinusitis, dermatophyte (tinea) infection) within 12 months prior to randomization\n17. History of opportunistic infection within 12 months prior to randomization unless evaluated and cleared by an infectious disease or pulmonary specialist\n18. Any of the following laboratory values during screening:\n\n    1. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 1.5 × upper limit of normal (ULN)\n    2. Platelet count \\\u003C 100 × 10\\^9\u002FL (100,000\u002Fmm\\^3)\n    3. Hemoglobin (Hb) \\\u003C 90 g\u002FL (9 g\u002FdL; 5.6 mmol\u002FL)\n    4. White blood cells \\\u003C 3.0 × 10\\^9\u002FL (3000\u002Fmm\\^3)\n    5. Absolute neutrophil count (ANC) \\\u003C 1.0 × 10\\^9\u002FL (1000\u002Fmm\\^3)\n19. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study",{"count":52,"type":21},78,"INTERVENTIONAL",[55],"PHASE2","This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance versus withdrawal in Giant cell arteritis (GCA) patients who are in remission after at least 12 months of high dose TCZ treatment. Eligible participants will also have discontinued glucocorticoids (e.g., prednisone (or equivalent)) entirely at least three months before randomization. High dose TCZ treatment includes 6-8 mg\u002Fkg intravenously (IV) monthly or 162 mg subcutaneously (SC) weekly, which are two forms of administration that are commonly used in clinical practice and are equally efficacious in controlling GCA\n\nThis research study has three parts:\n\n1. The screening phase (up to 42 days) consists of collecting information about your health and your GCA, a physical exam, and blood tests to see If you qualify to enroll in the study\n2. The study treatment phase (withdrawal\u002Fstep down dosing phase study months 0 - 18) consists of you either completely stopping or decreasing your current dose of tocilizumab while collecting information about your health and your GCA as well as blood samples every two months at clinic visits\n3. The safety follow-up phase (months 19-30) consists of collecting information about your health and your GCA as well as blood samples every three months\n\nThe primary objective is to determine the rate of disease relapse at 18 months in participants with GCA who receive low-dose TCZ compared to those who discontinue TCZ",[25],[59,60,61],"Tocilizumab","Giant Cell Arteritis","ACTEMRA(R)","RECRUITING","2026-06-04",{"date":65,"type":35},"2026-06-05",{"date":67,"type":35},"2025-12-11",{"date":69,"type":21},"2030-01-11",{"name":71,"class":72},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",7,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":16,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":53,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100639991","long-axial-field-of-view-lafov-18ffdg-petct-imaging-in-large-vessel-vasculitis-lvv-protocol-optimisation-study-100639991","NCT07628075","Long-Axial Field of View (LAFOV) [18F]FDG PET\u002FCT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.","LAVA-FLOW","Inclusion Criteria LVV Patients:\n\n* ≥18 years of age\n* Newly diagnosed LVV (based on the 2022 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) classification criteria or from a definite diagnosis of LVV on standard of care imaging)\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n* eGFR of ≥30 (mL\u002Fmin\u002F1.73m2) within 3 months of \\[18F\\]FDG injection in subjects who have a history of renal impairment, renal disease, renal transplant or diabetes\n\nExclusion Criteria LVV Patients:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* History of allergy to iodinated contrast\n* Commencement of steroids \\> 7 days prior to administration of the radiotracer\n* Poorly controlled diabetic with a blood glucose \\>11mmol\u002FL\n* Evidence of a significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.\n\nInclusion Criteria Healthy Volunteers:\n\n* Three subjects ≥18 years of age that are also \\\u003C 50 years old and three subjects ≥50 years of age\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n\nExclusion Criteria Healthy Volunteers:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* Participants with any contra-indication to MRI\n* Known allergy to gadolinium-based contrast agents\n* History of smoking\n* History or current diagnosis of the following medical conditions:\n* Diabetes Mellitus\n* Chronic Kidney Disease\n* Atrial Fibrillation\n* Migraines\n* Rheumatoid Arthritis\n* Systemic Lupus Erythematosus (SLE)\n* Historic or current prescription of the following medications:\n* Any blood pressure medication\n* Any antipsychotic medication\n* Steroids\n* Weight of ≥75Kg (in order to keep the radiation dose \\\u003C10mSV for HV)\n* Evidence of any significant medical condition which, in the opinion of the Investigator, makes it undesirable for the HV to participate in the trial\n* Participants that have undergone any imaging investigation that exposes them to radiation within the previous 12 months","18 Years",{"count":83,"type":21},18,[85],"NA","Large vessel vasculitis (LVV) is an autoimmune inflammatory disorder affecting the major arteries of the body. The diagnosis and monitoring this condition can be challenging, as patients often present with symptoms that are unclear, and the diagnostic criteria currently used are varied. Accurate diagnosis is essential because it helps to tailor the treatment to each patient. Some treatments, such as steroids and immunosuppressive medications, can have significant side effects, so they need to be used carefully and only when truly needed.\n\nAn \\[18F\\]FDG Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) involves the injection of a small amount of radiolabelled sugar, which assesses glucose metabolism within the body. \\[18F\\]FDG PET\u002FCT is already used by the NHS to detect inflammation within the vessel walls and diagnose LVV. Current diagnostic criteria for LVV largely rely on visual assessment by a radiologist. This approach therefore has limitations and may not fully capture changes in the levels of inflammation over time.\n\nA new generation of scanners, known as Long Axial Field-of-View (LAFOV)-PET\u002FCT or Total Body PET, are currently transforming what is possible in the field of medical imaging. These LAFOV-PET\u002FCT scanners have new digital detectors that are more sensitive, produce sharper images, and can scan the entire body rapidly. This offers several potential advantages for patients with LVV, including the clearer detection of vessel wall inflammation, the ability to administer lower doses of the radiolabelled sugar (\\[18F\\]FDG), and the ability to take repeated pictures over time to measure subtle changes in blood flow and inflammation. Patients receiving a routine NHS \\[18F\\]FDG PET\u002FCT scan for LVV are typically scanned 60 minutes after injection of the radiotracer using a standard PET\u002FCT. Another benefit of LAFOV-PET\u002FCT scanners is their ability to assess the amount of the radiolabelled sugar taken up by the whole body almost as soon as it is injected which could give important additional information.\n\nAs part of the LAVA-FLOW study we are planning to combine LAFOV-PET\u002FCT with a CT Angiogram (CTA) in patients with LVV. A CTA is a scan that shows doctors what your blood vessels look like. It involves the injection of a dye into a vein that makes your blood vessels visible, highlighting vessel wall inflammation and vessel wall narrowing. This combination of LAFOV-PET\u002FCT and CTA therefore has the potential to give a much more detailed picture of LVV than is achievable using current methods.\n\nThe LAVA-FLOW study therefore aims to develop a standardised protocol to be used in different hospital centres across the UK for the imaging of LVV using LAFOV-PET\u002FCT. We also hope that the results of this particular study could lead to further larger studies with the potential to update the diagnostic criteria and improve the monitoring of this condition.",[88,89,25],"Large Vessel Vasculitis","Takayasu Arteritis",[88,91,92,93],"[18F]FDG Long-Axial Field of View (LAFOV)-PET\u002FCT","Angiography","Protocol Optimisation","2026-06-01",{"date":63,"type":35},{"date":97,"type":21},"2026-07-01",{"date":99,"type":21},"2028-01-01",{"name":101,"class":42},"Imperial College London",3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":73},"100635434","disease-activity-monitoring-in-patients-with-giant-cell-arteritis-study-100635434","NCT07552636","Disease Activity Monitoring in Patients With Giant Cell Arteritis Study","Disease Activity Monitoring in Patients With Giant Cell Arteritis","DiAcMo","Inclusion Criteria:\n\n1. Clinical GCA diagnosis established\u002Fconfirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis \\\u003C 3 years.\n2. Clinical remission at the time of inclusion, defined as\n\n   * Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).\n   * Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.\n   * Normal CRP level (\\\u003C 10 mg\u002FL) within 7 days before inclusion.\n3. Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.\n4. A continuous tapering of monotherapy or combination therapy is planned.\n5. Age \\> 50 years.\n6. Study participants must be able to speak and understand spoken and written Danish.\n\nExclusion Criteria:\n\n1. Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.\n2. Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.\n3. Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.",{"count":112,"type":21},175,"Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the interleukin-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and\u002For predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.",[25],[116,117,118,119],"vascular ultrasonography","disease activity monitoring","giant cell arteritis","patient-reported outcome measures","2026-05-27",{"date":122,"type":35},"2026-05-29",{"date":124,"type":35},"2026-05-06",{"date":126,"type":21},"2029-02",{"name":128,"class":42},"University of Aarhus",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":43},"100608798","orbital-vascular-inflammation-in-ischemic-optic-neuropathy-and-giant-cell-arteritis-100608798","NCT07206238","Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis","VISION-GCA","Inclusion Criteria:\n\nFor AION group:\n\n* Clinical suspicion of newly onset ischemic optic neuropathy (A-AION or NA-AION), defined by ipsilateral findings of: Papilledema; Relevant visual impairment measured by visual acuity and\u002For visual field; Relative afferent pupillary defect (RAPD), except if mydriatic agents have been administered or if bilateral optic neuropathy is present.\n* Age ≥ 50 years\n\nFor GCA group:\n\n* Clinically- and ultrasound-confirmed, newly diagnosed GCA\n* Absence of visual changes related to GCA in one or both eyes, including: Transient vision loss; permanent vision loss; transient double vision; permanent double vision\n* Age ≥ 50 years\n\nExclusion Criteria:\n\n* Ferromagnetic implants\n* Severe renal impairment with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²\n* Allergy to MRI contrast agents\n* Severe claustrophobia\n* Pregnancy or breastfeeding\n* Previously documented ipsilateral optic neuropathy or giant cell arteritis\n* More than 5 days of treatment with prednisolone prior to inclusion",{"count":137,"type":21},122,"Giant cell arteritis (GCA) is an inflammation of the blood vessels. A dangerous complication is sudden vision loss due to insufficient blood supply to the optic nerve. However, it is often difficult to distinguish acute vision loss due to GCA from a similar condition of insufficient blood supply to the optic nerve, called NAION. Quick treatment with anti-inflammatory medication is needed in case of GCA to prevent vision loss on the eye and other serious complications. Patients with NAION have no benefit of the medication, but can have serious side effects, why it is very important to differentiate between these conditions.\n\nIn this project, the investigators will use FDG PET\u002FMRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and\u002For ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit using PET\u002FMRI and study subtle retinal changes using OCT images.\n\nThe investigators want to answer the following research questions:\n\nDo patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET\u002FMRI-scans, that are not present in patients with NAION?\n\nDo GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET\u002FMRI-scans, have a higher risk of later vision loss than GCA patients without?\n\nCan subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION?\n\nThis will, to our knowledge, be the first study to systematically use FDG PET\u002FMRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and\u002For ischemic optic nerve disease. The results may improve diagnosis and treatment of GCA and NAION in the future. The investigators hope that this will help prevent blindness and other serious complications in patients with GCA, while also avoiding unnecessary treatments for patients with NAION.",[25,140,141],"Ischemic Optic Neuropathy","NAION - Non-Arteritic Ischemic Optic Neuropathy",[143,144,145,27,146],"FDG PET\u002FMRI BB","OCT","Retinal biomarkers","ischemic optic neuropathy","2026-05-02",{"date":149,"type":35},"2026-05-07",{"date":151,"type":35},"2026-01-14",{"date":153,"type":21},"2029-03-30",{"name":155,"class":42},"Rigshospitalet, Denmark",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":53,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":43},"100589637","phase-2-bosentan-in-the-treatment-of-giant-cell-arteritis-100589637","NCT06957002","Bosentan in the Treatment of Giant Cell Arteritis","Bosentan in the Treatment of Giant Cell Arteritis. Multicenter, Randomized, Controlled, Superiority Phase II Trial Comparing a Combination of Bosentan and Glucocorticoids Versus Glucocorticoids Alone in the Treatment of Patients With GCA","BOSICART","* Inclusion Criteria :\n* Patients having given their written informed consent prior to participation in the study\n* Patients affiliated with social security or CMU (profit or being entitled)\n* Diagnosis of GCA, as defined by the revised GCA diagnosis criteria. Patients must satisfy criteria 1-2-3 and 4 (irrespective of time):\n\n  * Age ≥50 years at disease onset\n  * History of erythrocyte sedimentation rate (ESR) ≥ 50 mm\u002Fh or CRP ≥ 20 mg\u002FL (not mandatory if TAB is positive: see below)\n  * At least one of the following:\n* unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss)\n* unequivocal symptoms of polymyalgia rheumatica (PMR)\n\n  * At least one of the following:\n* Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing vasculitis with a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)\n* Evidence of large vessel vasculitis:\n\n  * angio-CT or angio-MRI: thickened and\u002For contrast-enhanced arteries especially aorta (≥2mm) and epiaortic arteries (≥1mm) and contrast enhanced arteries in T1-weighted sequences\n  * or PET scan: ≥ grade 2 (from 0 to 3) tracer uptake on large arteries\n* At least a sign of active GCA within the 2 weeks prior to randomisation. Active GCA is defined by ESR ≥30 mm\u002Fh or CRP ≥10 mg\u002FL and at least one of the following:\n* unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)\n* unequivocal symptoms of PMR, defined as shoulder and\u002For hip girdle pain associated with inflammatory stiffness\n* other features judged by the clinical investigator to be consistent with GCA or PMR flares\n* Menopausal women (no gynaecological cycle over the past two years), or women who had a gynaecological cycle within previous 24 months (non-menopausal women) only if they have (1) an effective non hormonal contraceptive method throughout study and (2) a negative urinary beta-hCG test at inclusion.\n\nExclusion Criteria:\n\n* Patients under maintenance of justice, wardship or legal guardianship\n* Patient unable to give written informed consent prior to participation in the study\n* Patients included in other investigational therapeutic study within the previous 3 months\n* Patients suspected not to be observant to the proposed treatments\n* Weight \\\u003C40 Kg or \\> 100 Kg\n* Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C. History of chronic alcohol abuse (consumption \\> 20 g\u002Fday)\n* Severe chronic heart failure or severe systolic dysfunction\n* Recent (\\\u003C 3 months) or incoming surgery requiring a general anaesthesia\n* History of stem cell or organ transplantation (except corneas if performed more than 3 months prior inclusion)\n* Hypersensitivity to bosentan or one of its excipients\n* Prior treatment with any of the following:\n\n  * Tocilizumab or methotrexate or secukinumab within 12 weeks preceding inclusion\n  * Cell-depleting agents (i.e., anti-CD20)\n  * Alkylating agents including cyclophosphamide\n  * Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil or janus kinase inhibitors within 4 weeks preceding inclusion\n  * Tumor necrosis factor inhibitors within 8 weeks preceding inclusion\n  * Anakinra within 1 week preceding inclusion\n* Ongoing treatment with glibenclamide, fluconazole and rifampicin. Concomitant administration of both a CYP3A4 inhibitor or a CYP2C9 inhibitor\n* Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR\n* Laboratory abnormalities: AST or ALT \\>3 x upper limit of normal (ULN)\n* Infections:\n\n  * Active hepatitis B or C\n  * HIV infection",{"count":165,"type":21},40,[55],"The purpose of this study is to determine whether a treatment with 3 months of bosentan associated to standard therapy might be superior to glucocorticoids alone in term of failure free survival at 12 months",[25],[60,170],"Bosentan","2026-04-30",{"date":124,"type":35},{"date":174,"type":21},"2026-06",{"date":176,"type":21},"2030-06",{"name":178,"class":42},"Assistance Publique - Hôpitaux de Paris",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":53,"phases":189,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":43},"100580139","phase-3-treatment-for-giant-cell-arteritis-with-tocilizumab-and-8-as-compared-to-26-weeks-of-prednisone-100580139","NCT06833411","Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone","Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study","GISCO","Inclusion Criteria:\n\n* Patients diagnosed with giant cell arteritis\n* Start of tocilizumab treatment at baseline as part of routine clinical practice\n* Receive ≥ 20 mg\u002Fday prednisone (or equivalent) at baseline\n* Written informed consent\n\nExclusion Criteria:\n\n* Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.",{"count":188,"type":21},178,[190],"PHASE3","The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis\n\n* with tocilizumab,\n* while using less cortisone.",[25],[59,194,195,27],"Glucocorticoid","Prednisone",{"date":197,"type":35},"2026-05-01",{"date":199,"type":21},"2026-07",{"date":201,"type":21},"2032-08",{"name":203,"class":42},"Insel Gruppe AG, University Hospital Bern",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":16,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":43},"100611899","the-vgr-gca-cohort-ultrasound-biopsy-and-biomarkers---novel-methods-for-diagnosis-monitoring-and-prognosis-in-giant-cell-arteritis-100611899","NCT07246577","The VGR GCA Cohort: Ultrasound, Biopsy and Biomarkers - Novel Methods for Diagnosis, Monitoring and Prognosis in Giant Cell Arteritis.","The VGR GCA Cohort","Inclusion Criteria\n\n* Individuals referred for evaluation due to suspected giant cell arteritis (GCA).\n* Ability to provide written informed consent.\n\nExclusion Criteria\n\n* Previous diagnosis of GCA.\n* Previous temporal artery biopsy performed as part of prior GCA evaluation.\n* Treatment with high-dose corticosteroids (\\>7.5 mg\u002Fday) for more than two weeks before initiation of the diagnostic work-up.\n* Inability to provide informed consent.\n* Inability to comply with the study protocol.",{"count":212,"type":21},340,"Giant cell arteritis (GCA) is the most common vasculitis in the elderly and is usually treated with long-term corticosteroid therapy. Many patients experience relapses and treatment-related side effects. Current diagnostic and monitoring methods provide limited prognostic information and cannot reliably distinguish active from inactive disease during relapse. This project addresses the clinical need for improved tools to identify patients at high risk of relapse and to develop more effective methods for disease monitoring.\n\nThe aim is to develop new tools that enable more personalized treatment of GCA. By combining vascular ultrasound with novel blood biomarkers, we seek to predict disease course and relapse risk. The specific objectives are:\n\n* To identify ultrasound and blood biomarkers that can predict long-term disease control.\n* To determine which ultrasound parameters and blood biomarkers can distinguish active from inactive disease during treatment.\n* To evaluate whether extended vascular ultrasound protocols can improve diagnostic accuracy.\n\nThe ultimate goal is to establish safe, practical tools for improved diagnosis and follow-up in patients with GCA.",[25],[216,217,60,218,219,220,221],"Prospective Studies","Validation Study","Ultrasonography","Biomarkers","Temporal Arteries","Biopsy","2026-04-14",{"date":224,"type":35},"2026-04-15",{"date":226,"type":35},"2026-03-01",{"date":228,"type":21},"2029-12-01",{"name":230,"class":231},"Vastra Gotaland Region","OTHER_GOV",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100623272","study-of-the-association-between-sacroiliitisaxial-spondylarthritis-and-giant-cell-arteritis-polymyalgia-rheumatica-100623272","NCT07394478","Study of the Association Between Sacroiliitis\u002FAxial Spondylarthritis and Giant Cell Arteritis\u002F Polymyalgia Rheumatica","Study of the Association Between Sacroiliitis\u002FAxial Spondylarthritis and Giant Cell Arteritis\u002F Polymyalgia Rheumatica: A Case-control Observational Study","SAGE PPR","Inclusion Criteria:\n\n* Experimental group: Adult patient with spondylitis associated with GCA or PMR Control group: Adult patient with GCA or PMR\n\nExclusion Criteria:\n\n* Refusal to participate\n* Positive anti CCP",{"count":241,"type":21},10,"The purpose of the study is to recruit as many patients as possible presenting with sacroiliitis or authentic axial spondylarthritis and giant cell arteritis. The investigators will also be interested in the association of spondylarthritis and polymyalgia rheumatica given the continuum between these two pathologies. The aim is to investigate whether there is an association between giant cell arteritis and spondylarthritis or polymyalgia rheumatica and spondylarthritis.",[25,244,245],"Spondylarthritis","Polymyalgia Rheumatica",[25,244,247],"Polymyalgia rheumatica","2026-02-03",{"date":250,"type":35},"2026-02-06",{"date":252,"type":21},"2026-02-01",{"date":254,"type":21},"2026-06-30",{"name":256,"class":42},"Hôpital NOVO",2,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":266,"targetDuration":268,"studyType":22,"phases":4,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100620229","upadacitinib-in-giant-cell-arteritis-gca-with-active-large-vessel-involvement-100620229","NCT07354906","Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.","Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.","TILT2","Inclusion Criteria:\n\nPatients aged over 18 years; Signed informed consent; Affiliation with the French national social security system; Diagnosis of newly diagnosed or relapsing GCA according to the 2022 ACR\u002FEULAR criteria; Active aortitis related to GCA demonstrated by imaging (CT angiography, MR angiography, and\u002For PET-CT); Indication for treatment with an anti-JAK agent within the scope of the marketing authorization for GCA: failure of, intolerance to, or contraindication to tocilizumab therapy; No contraindication to JAK inhibitors.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding (for women of childbearing potential, a negative serum pregnancy test will be required); History of severe immunosuppression, HIV infection, hepatitis C virus (HCV), or positive hepatitis B surface antigen (HBsAg); Non-response to or intolerance of a previous anti-JAK treatment; Positive QuantiFERON test (QFT-TB Gold In-Tube) indicating active tuberculosis (latent tuberculosis under treatment for at least 3 weeks may be included); Receipt of live vaccines within the 3 months preceding treatment initiation; History of malignancy within the past 5 years; Severe renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin\u002F1.73 m²); Hepatic dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≥ 5 times the upper limit of normal;\n\nAbnormal blood counts:\n\nPlatelets \\\u003C 50 × 10³\u002Fmm³; Neutropenia \\\u003C 1,000\u002Fmm³; Hemoglobin \\\u003C 8 g\u002FdL; History of thromboembolic disease; History of severe cardiovascular disease.",{"count":267,"type":21},80,"24 Months","Participants will be followed as part of the usual management of their disease. No modifications will be made (no additional visits, examinations, or questionnaires). The safety and well-being of participants will therefore remain unchanged.\n\nThe participant will be informed about the study during one of their routine care visits. The information will be provided by the investigator, and the participant's non-opposition to participation in the study will be obtained.\n\nThe participant will continue to be followed as part of their usual care.\n\nData will then be collected from the participant's medical record (including medical reports, original laboratory test results, imaging reports and medical examinations, and nursing records) for the period of participation in the research, solely for the purpose of meeting the objectives of the research.\n\nThe data collected will consist of information from the patient's medical record as part of their routine follow-up and will be strictly necessary to address the primary and secondary objectives of the study. The following data will be collected: demographic data (age, sex, weight, height); clinical data (medical history, diagnosed condition, disease activity), treatments, biological data, imaging data, and adverse events. No genetic data will be collected as part of the study. There will be no transfer of data abroad, and no additional questionnaires, examinations, or visits will be added by the research.",[25],[272,273,274],"Giant Cell Arteritis (GCA) .","Upadacitinib","Efficacy","2026-01-12",{"date":277,"type":35},"2026-01-21",{"date":226,"type":21},{"date":280,"type":21},"2030-03-30",{"name":282,"class":42},"Groupe français d'étude des Maladies Inflammatoires de loeil",14,{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":16,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":53,"phases":293,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":43},"100584263","phase-2-dapagliflozin-and-endothelin-receptor-antagonism-in-large-vessel-vasculitis-derail-lvv-100584263","NCT06887062","Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)","DERAIL-LVV","Inclusion Criteria:\n\n* A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Active LVV\n* Any organ transplant recipients\n* A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin\n* Congestive cardiac failure\n* Patients not medically fit to attend study visits\n* Patients without mental capacity or willingness to provide informed consent\n* History of multiple and\u002For severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food\n* Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study\n* Participation in another clinical trial for 28 days before or 90 days after the study period",{"count":292,"type":21},60,[55],"Large vessel vasculitis (LVV) is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase.\n\nIt has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin.\n\nDapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been shown to improve blood vessel function and stiffness in patients with diabetes.\n\nThe investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will be given Bosentan and Dapagliflozin for 6 weeks, followed by Dapagliflozin for 4 weeks, to evaluate their impact on blood vessel function.",[88,25,89],[297,298,27,299,170,300,301,302,303,304],"Large vessel vasculitis","Takayasu arteritis","Endothelin","Inflammation","Endothelial dysfunction","Dual enodthelin receptor antagonism","dapagliflozin","SGLT2 inhibitor",{"date":151,"type":35},{"date":307,"type":35},"2025-03-21",{"date":309,"type":21},"2027-07-01",{"name":41,"class":42},{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":53,"phases":321,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":102},"100454119","phase-4-hydrocortisone-and-placebo-in-patients-with-symptoms-of-adrenal-insufficiency-after-cessation-of-glucocorticoid-treatment-100454119","NCT05193396","Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment","A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)\u002F Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.","REPLACE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* A diagnosis of PMR or GCA in GC free remission for \\>2 week and \\\u003C12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing´s syndrome\n* Heart failure (New York Heart Association class IV)\n* Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\n* Liver cirrhosis\n* Active cancer\n* Known severe immune deficiency\n* A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)\n* Alcohol consumption \\>21 units per week\n* Planned major surgery during the study period at study entry\n* Use of drugs that interfere with cortisol metabolism\u002Fmeasurements:\n* Systemic oestrogen treatment within 1 month before study inclusion\n* Strong CYP3A4 inhibitors or inducers\n* Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area\n* Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area\n* Inability to provide written informed consent",{"count":320,"type":21},100,[322],"PHASE4","Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, new evidence suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, it was observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This observation aligns with the clinical experience that PMR\u002FGCA patients often complain of fatigue after planned cessation of prednisolone treatment. This often occurs in the absence of objective symptoms or signs of residual PMR\u002FGCA disease activity. The scenario has been designated as \"the steroid withdrawal syndrome\". This may represent a state of relative adrenal insufficiency prompted by long term, high dose prednisolone treatment. The proper way to tackle this clinical conundrum is to perform a proper randomized trial, which so far has not been conducted.\n\nTherefore, investigators of this study will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. Investigators argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. The study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.",[325,326,25],"Adrenal Insufficiency","Polymyalgia Rheumatica (PMR)",[328],"tertiary adrenal insufficiency","2025-12-15",{"date":331,"type":35},"2025-12-22",{"date":333,"type":35},"2022-02-01",{"date":335,"type":21},"2026-01",{"name":337,"class":42},"Marianne Andersen",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":53,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"100593024","optic-nerve-sheath-evaluation-in-giant-cell-artheritis-by-ultrasound-100593024","NCT07001059","oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound","PETRUS","Inclusion Criteria:\n\n* Patient with suspected GCA\n* Patient over 50 years\n\nExclusion Criteria:\n\n* Patient with history of GCA\n* Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan\n* Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension\n* Use of corticosteroids \\> 0.5mg\u002Fkg in the last 2 weeks",{"count":346,"type":21},190,[85],"The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis",[25],[60,351,352],"Optic nerve sheath","Ultrasound","2025-09-08",{"date":355,"type":35},"2025-09-12",{"date":357,"type":35},"2025-09-04",{"date":359,"type":21},"2028-03-31",{"name":256,"class":42},9,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":43},"100562938","pilot-study-to-evaluatethrombomodulin-to-rule-out-giant-cell-arteritis-gca-in-polymyalgia-rheumatica-pmr-patients-thropiq-100562938","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)",{"count":52,"type":21},"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.",[25,326],"2025-09-02",{"date":374,"type":35},"2025-09-09",{"date":376,"type":35},"2024-10-10",{"date":378,"type":21},"2027-10",{"name":380,"class":42},"Centre Hospitalier Universitaire Dijon",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":16,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":43},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",{"count":390,"type":21},120,"The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[393,394,25,395,396,326,397,398,399,400,401,402,403],"Rheumatic Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","ANCA Associated Vasculitis (AAV)","Connective Tissue Disease (CTD)","Systemic Sclerosis (SSc)","Systemic Lupus Erthematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":372,"type":35},{"date":407,"type":35},"2025-04-01",{"date":409,"type":21},"2028-12",{"name":411,"class":42},"University of Bonn",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":53,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":438},"100597575","halo-sign-vanishing-time-after-steroids-outbreak-in-gca-patients-100597575","NCT07060274","Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients","Halo-A","Inclusion Criteria:\n\n* Patients aged 50 and over\n* Without legal protection.\n* Meeting GCA classification criteria as defined by ACR 2022.\n* Newly diagnosed with an indication for corticosteroid treatment.\n* Have not yet received corticosteroid treatment for GCA.\n* No contraindication to corticosteroid treatment.\n* Person affiliated with or benefiting from a social security scheme.\n* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).\n\nExclusion Criteria:\n\n* Patients with a relapse of Giant Cell Arteritis (GCA).\n* Patients who have previously undergone a temporal artery biopsy (TAB), including for other reasons.\n* Patients who have received oral corticosteroid treatment in the past month or are currently on corticosteroid therapy (excluding hydrocortisone or local corticosteroids).\n* Patients with other types of vasculitis that may constitute a differential diagnosis: presence of antibodies against the cytoplasm of neutrophils (ANCA), positive syphilis serology, positivity of an IGRA test (Interferon Gamma Release Assay).\n* Patients having received immunosuppressive treatment or biotherapy in the month prior to inclusion. If the patient's condition warrants the use of biotherapy or immunosuppressive treatment, its initiation will be delayed until after Day 7 to avoid interfering with the Doppler procedure.",{"count":420,"type":21},64,[85],"Giant cell arteritis (GCA) is a rare disease characterized by vasculitis of the large arterial trunks targeting the thoracic aorta and its dividing branches, affecting adults over the age of 50. Vasculitis lesions cause thickening of the arterial wall, visible on temporal artery biopsy (TAB) or vascular imaging (echo-Doppler, angio-CT, angio-MRI, 18FDG PET-CT). This is a severe disease that can lead to blindness. Early diagnosis is essential, so that steroids therapy can be started as soon as possible to prevent complications. Doppler ultrasonography of the temporal arteries provides rapid, non-invasive diagnostic support. However, the recommendations do not specify how soon temporal artery Doppler should be performed after steroids treatment, except that the halo sign would disappear after about 5 days on steroids. Sensitivity seems to be better when the examination is performed early, but the time taken for the halo sign to disappear is unknown. The investigator suggests that the disappearance of the temporal artery halo sign in GCA patients is observed earlier than D14 of steroids treatment usually reported in the literature. He speculates that the sensitivity of the temporal artery Doppler decreases as early as D3 of steroids treatment, and that beyond D7 it is not useful to perform this examination as its sensitivity becomes too low.",[25,424],"Doppler Ultrasound",[27,426,427,428,429],"echo-Doppler","Doppler ultrasonography","Halo sign","steroids","2025-07-01",{"date":432,"type":35},"2025-07-11",{"date":434,"type":21},"2025-09",{"date":378,"type":21},{"name":437,"class":42},"Centre Hospitalier le Mans",6,{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":447,"conditions":448,"keywords":449,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":43},"100573160","performance-of-a-fast-track-pathway-for-giant-cell-arteritis-diagnosis-100573160","NCT06742671","Performance of a Fast-track Pathway for Giant Cell Arteritis Diagnosis","QuickDx-GCA","Inclusion Criteria:\n\n* Patient suspected of GCA\n\nExclusion Criteria:\n\n* Opposition to the use of their data",{"count":320,"type":21},"Giant cell arteritis is a vasculitis, i.e. inflammation of the artery walls, which generally affects people over the age of 50. Diagnosis can be long and difficult, as the clinical signs are not specific (headache, pain in the jaw, scalp, shoulders and\u002For pelvis, abdominal pain, weight loss, etc.), but it must be made quickly, given the risk of complications.\n\nThe reference method for diagnosis was initially based on clinical suspicion and analysis of a \"piece of temporal artery\" (biopsy) performed in the operating theatre under local anaesthetic. Since the mid-1990s, improvements in ultrasound techniques have made it possible to identify a sign, known as a halo, on the temporal arteries that is typical of patients with Giant Cell Arteritis. A prospective multicenter study published in 2024 demonstrated that, in patients with a clinical suspicion of Giant Cell Arteritis, if a halo was found on both temporal arteries by ultrasound, there was no need for a biopsy. This study is at the origin of a change in practices in the diagnosis and care of patients suffering from this disabling disease.\n\nTo facilitate early diagnosis, a fast-track pathway has been set up. The aim is to make a rapid diagnosis, thereby reducing the risk of after-effects, shortening the length of hospital stays, considering outpatient treatment and limiting the number of biopsies.\n\nThe investigators propose to evaluate the performance of this fast-track pathway.",[25],[450,451,452,453],"diagnostic test","ultrasonography, Doppler, color","temporal arteries, biopsy","fast track clinic","2025-06-17",{"date":456,"type":35},"2025-06-20",{"date":458,"type":35},"2025-02-14",{"date":460,"type":21},"2027-03-31",{"name":462,"class":42},"Groupe Hospitalier de la Rochelle Ré Aunis",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":16,"sex":471,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":474,"conditions":475,"keywords":484,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":496,"locationsCount":43},"100569575","aylo---autoimmunity-and-loss-of-y-100569575","NCT06696027","AYLo - AutoimmunitY and Loss of y","Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases","AYLo","Inclusion Criteria:\n\n* Male\n* \\> 50 years\n* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.\n\nExclusion Criteria:\n\n* Female\n* \\\u003C 50 years\n\nInclusion Criteria (Healthy controls):\n\n* Male\n* \\> 50 years\n\nExclusion Criteria (Healthy controls):\n\n* Female\n* \\\u003C 50 years\n* autoimmune, rheumatological diease\n* pulmonary precondition","MALE",{"count":473,"type":21},500,"The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.\n\nThrough the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.\n\nA further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.\n\nAdditionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.\n\nBy integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.",[25,326,397,476,477,394,395,478,479,480,481,482,483],"Idiopathic Inflammatory Myopathies","IgG4-Related Diseases","Connective Tissue Disease","Sarcoidosis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[485,28,88,60,245,486,476,477,487,488,478,479,489],"Autoimmune Diseases","ANCA Associated Vasculitis","Rheumatoid Arthritis","Psoriatic Arthritis","Interstitial Lung Disease","2025-04-07",{"date":492,"type":35},"2025-04-10",{"date":494,"type":35},"2024-11-15",{"date":199,"type":21},{"name":411,"class":42},{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":43},"100476093","predictive-factors-for-treatment-response-in-patients-with-newly-diagnosed-polymyalgia-rheumatica-and-giant-cell-arteritis-100476093","NCT05479448","Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis","Inclusion Criteria:\n\n* Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria\n* Consent to participate in the SCQM database\n* Treatment according to our standardized regimes\n\nExclusion Criteria:\n\n* Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion\n* History of GCA and PMR in the past\n* Inability to give informed consent",{"count":20,"type":21},"This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and\u002For GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR\u002FGCA to GCs.",[326,25],[507,508,509,510,511,512,513,514,515,516,517],"Large vessel vasculitis (LVV)","Glucocorticoid receptor (GCR)","glucocorticoid (GC)","steroid-response","GCR expression levels","GCR sensitivity\u002Fresponsiveness","prednisolone","prednisone","Swiss Clinical Quality Management in Rheumatic Diseases (SCQM)","Glucocorticoid resistance","endogenous GC suppression","2025-03-31",{"date":407,"type":35},{"date":521,"type":35},"2022-06-03",{"date":409,"type":21},{"name":524,"class":42},"University Hospital, Basel, Switzerland",{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":43},"100574997","a-registry-study-assessing-pro-dosing-patterns-and-safety-of-vunakizumab-in-patients-with-general-rheumatic-diseases-100574997","NCT06766552","A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","V-MIRACLE","Inclusion Criteria:\n\n1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis\u002Fradiologically negative axial spondyloarthritis\u002Fpsoriatic arthritis\u002Fpolymyalgia rheumatica\u002FTakayasu arteritis\u002Fgiant cell arteritis\u002F non-ocular Behcet's disease\u002F enthesitis-related arthritis;\n2. Currently receiving or planning to receive fulvezinib treatment;\n3. Can follow up according to the doctor's advice;\n4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study.\n\nExclusion Criteria:\n\n1.Investigator believes will prevent the subject from following and completing the study protocol",{"count":534,"type":21},10000,"Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.",[537,395,538,326,539,25,540,541],"Ankylosing Spondylitis (AS)","Nr-axSpA","Takayasu Arteritis (TAK)","Behcet's Disease","Enthesitis-related Arthritis","2025-01-08",{"date":544,"type":35},"2025-01-09",{"date":546,"type":21},"2025-01-30",{"date":548,"type":21},"2030-06-30",{"name":550,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":43},"100536914","tocilizumab-in-aortitis-in-gca-tilt-100536914","NCT06271018","TocILizumab in aorTitis in GCA (TILT)","Prospective, Observational Study Assessing Safety and Efficacy of Biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) With Active Aortitis","TILT","Inclusion Criteria:\n\n* Patients ≥18 years\n* Signed informed consent\n* Affiliation with the French national social security system\n* Adequate and effective contraceptive measures\n* For women of childbearing age, a negative serum pregnancy test.\n* Diagnosis of GCA according to 2022 ACR\u002FEULAR criteria\n* Active newly diagnosed or relapsing Aortitis related to GCA proved by imaging (Tep-scan, angio-CT or magnetic resonance imaging angiography)\n* No neoplasia\n* No contraindication to Tocilizumab\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding ;\n* History of severe immunosuppression, HIV or HBsAg positive\n* Non response or intolerance to previous therapy with tocilizumab\n* Positive QuantiFERON test result (QFT-TBGIn-Tube)\n* Have received live vaccines within 3 months prior to the start of the trial\n* History of malignancy in the last 5 years\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin\u002F1.73m²)\n* Liver dysfunction defined as aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 at the upper limit of normal\n* Blood count abnormality:\n\n  * Platelet count \\\u003C 50 x 10.3\u002Fmm3\n  * Neutropenia \\\u003C 1000\u002Fmm3\n  * Hemoglobin \\\u003C 8 g\u002Fdl",{"count":267,"type":21},"This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).\n\nGiant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.\n\nMultiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.\n\nThe GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.\n\nFollowing the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.\n\nHowever, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.\n\nThis observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA.",[562,25],"Aortitis",[25,562,59],"2024-12-18",{"date":566,"type":35},"2024-12-20",{"date":568,"type":35},"2024-03-27",{"date":570,"type":21},"2028-03-27",{"name":282,"class":42}]