Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT06957002
Eligibility Criteria:
* Inclusion Criteria :
* Patients having given their written informed consent prior to participation in the study
* Patients affiliated with social security or CMU (profit or being entitled)
* Diagnosis of GCA, as defined by the revised GCA diagnosis criteria. Patients must satisfy criteria 1-2-3 and 4 (irrespective of time):
* Age ≥50 years at disease onset
* History of erythrocyte sedimentation rate (ESR) ≥ 50 mm/h or CRP ≥ 20 mg/L (not mandatory if TAB is positive: see below)
* At least one of the following:
* unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss)
* unequivocal symptoms of polymyalgia rheumatica (PMR)
* At least one of the following:
* 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)
* Evidence of large vessel vasculitis:
* angio-CT or angio-MRI: thickened and/or contrast-enhanced arteries especially aorta (≥2mm) and epiaortic arteries (≥1mm) and contrast enhanced arteries in T1-weighted sequences
* or PET scan: ≥ grade 2 (from 0 to 3) tracer uptake on large arteries
* At least a sign of active GCA within the 2 weeks prior to randomisation. Active GCA is defined by ESR ≥30 mm/h or CRP ≥10 mg/L and at least one of the following:
* 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)
* unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
* other features judged by the clinical investigator to be consistent with GCA or PMR flares
* 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.
Exclusion Criteria:
* Patients under maintenance of justice, wardship or legal guardianship
* Patient unable to give written informed consent prior to participation in the study
* Patients included in other investigational therapeutic study within the previous 3 months
* Patients suspected not to be observant to the proposed treatments
* Weight \<40 Kg or \> 100 Kg
* Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C. History of chronic alcohol abuse (consumption \> 20 g/day)
* Severe chronic heart failure or severe systolic dysfunction
* Recent (\< 3 months) or incoming surgery requiring a general anaesthesia
* History of stem cell or organ transplantation (except corneas if performed more than 3 months prior inclusion)
* Hypersensitivity to bosentan or one of its excipients
* Prior treatment with any of the following:
* Tocilizumab or methotrexate or secukinumab within 12 weeks preceding inclusion
* Cell-depleting agents (i.e., anti-CD20)
* Alkylating agents including cyclophosphamide
* Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil or janus kinase inhibitors within 4 weeks preceding inclusion
* Tumor necrosis factor inhibitors within 8 weeks preceding inclusion
* Anakinra within 1 week preceding inclusion
* Ongoing treatment with glibenclamide, fluconazole and rifampicin. Concomitant administration of both a CYP3A4 inhibitor or a CYP2C9 inhibitor
* Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR
* Laboratory abnormalities: AST or ALT \>3 x upper limit of normal (ULN)
* Infections:
* Active hepatitis B or C
* HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06957002
Study Brief:
Protocol Section:
NCT06957002