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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	30 April 2019
Main ID:	EUCTR2018-002826-22-FR
Date of registration:	21/11/2018
Prospective Registration:	Yes
Primary sponsor:	CHU Dijon Bourgogne
Public title:	MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA
Scientific title:	MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA
Date of first enrolment:	07/03/2019
Target sample size:	200
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002826-22
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
France

Contacts

Name:	Chef de projets recherche
Address:	1 Boulevard Jeanne d'Arc Dijon France
Telephone:
Email:
Affiliation:	CHU Dijon Bourgogne

Name:	Chef de projets recherche
Address:	1 Boulevard Jeanne d'Arc Dijon France
Telephone:
Email:
Affiliation:	CHU Dijon Bourgogne

Key inclusion & exclusion 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:
- 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
- Weight<40 Kg or >100Kg
- 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®).

Age minimum:
Age maximum:
Gender:
Female: no
Male: no

Health Condition(s) or Problem(s) studied

MedDRA version: 20.0 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: METOJECT
Pharmaceutical Form: Solution for injection

Trade Name: RoActemra
Pharmaceutical Form: Solution for injection in pre-filled syringe

Primary Outcome(s)

Main Objective:

Primary end point(s):

Secondary Objective:

Secondary Outcome(s)

Secondary ID(s)

BONNOTTE-PHRCN-2017

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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