MedDRA version: 20.0 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: METOJECT
Pharmaceutical Form: Solution for injection
Trade Name: RoActemra
Pharmaceutical Form: Solution for injection in pre-filled syring
Sponsors
CHU Dijon Bourgogne
Eligibility
Inclusion criteria
Inclusion criteria: - Written consent - Affiliation to a social security system - Diagnosis of GCA, as defined by the revised GCA diagnosis criteria: o Age =50 years at disease onset o AND History of erythrocyte sedimentation rate (ESR) =50 mm/h OR CRP=20 mg/L (not mandatory if TAB is positive: see below) o AND 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) o AND 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) * AND/OR Evidence of large vessel vasculitis (aorta and/or epiaortic arteries): • angio-CT or angio-MRI: thickened arterial wall (=2mm for the aorta and =1mm for epiaortic arteries) and/or contrast-enhanced arteries in T1-weighted sequences • PET scan: grade 3 tracer uptake of the arterial wall (grade 3 = arterial SUVmax superior to the SUVmax of the liver) - Active GCA within 6 weeks before randomization. Active GCA is defined by ESR =30 mm/h or CRP =10 mg/L and at least one of the following: o =1 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) o OR =1 unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness o OR any other feature(s) judged by the clinical investigator to be consistent with GCA or PMR flares Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Uncontrolled psychotic state - Patient unable to give his/her consent - Premenopausal women (menopause is defined as amenorrhea for more than 12 consecutive months) - Non-compliant patients - Weight100Kg - Patient under maintenance of justice, wardship or legal guardianship - History of intoxication (alcohol or medication) requiring hospitalization within 12 months before inclusion - History of chronic alcohol abuse (consumption > 20g/day) - Recent or incoming surgery within 12 months after inclusion - History of stem cell or organ transplantation (except corneas if performed more than 3 months prior inclusion) - Primary or secondary immunodeficiency - Hypersensitivity to methotrexate or tocilizumab, one of its excipients or another human or murine monoclonal antibody - History of diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal tract condition that might predispose to bowel perforation - Prior treatment with any of the following: o Tocilizumab or methotrexate within 12 weeks before inclusion o Cell-depleting agents (i.e., anti-CD20) o Alkylating agents including cyclophosphamide o Hydroxychloroquine, cyclosporine A, dapsone, azathioprine or mycophenolate mofetil or janus kinase inhibitors within 4 weeks before inclusion o Tumor necrosis factor inhibitors within 8 weeks (infliximab) or 2 weeks (adalimumab or etanercept) before inclusion o Anakinra within 1 week before inclusion - Long-term systemic glucocorticoid therapy for other conditions than GCA or PMR - Patient with =3 prior glucocorticoid systemic therapies for another disease than GCA or PMR within 6 months before inclusion - Long-term treatment with sulfamethoxazole/trimethoprim (Bactrim®) - Live vaccine administered within 30 days before inclusion - Laboratory abnormalities: o AST or ALT >1.5 x upper limit of normal (ULN) o total bilirubin >ULN o platelets<100 G/L o leukocytes <3 G/L o neutropenia <1.5 G/L o lymphopenia <0.5 G/L o clearance of creatinine <30 ml/min/1,73 m2 [CKD EPI 2009] o positive HBs antigens or positive HCV antibodies - Infections: o History of viral hepatitis B or C (chronic or acute) o HIV infection o Persistent infection or severe infection requiring hospitalization or intravenous antibiotics within 30 days before inclusion (antibiotic treatment tests are allowed, regardless of duration and route of administration) o Proven infection requiring oral antibiotics within 14 days before inclusion (antibiotic treatment tests are allowed, regardless of duration and route of administration) o Prior history of histoplasmosis or listeriosis o Active tuberculosis o Signs of latent tuberculosis (based on a history of non-treated contact, opacity with a diameter greater than 1 cm on chest radiography, or positive in vitro test: Quantiferon Gold® or T-Spot-TB®).
Design outcomes
Primary
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| Main Objective: ;Secondary Objective: ;Primary end point(s): | — |
Countries
France
Contacts
Public ContactChef de projets recherche
CHU Dijon Bourgogne
Outcome results
None listed