NCT03892785View on ClinicalTrials.gov

MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

January 27, 2020

Primary Completion Date

January 31, 2026

Study Completion Date

March 31, 2027

Conditions
Giant Cell Arteritis
Interventions
DRUG

Prednisone treatment

tapering prednisone regimen

DRUG

Tocilizumab treatment

Tocilizumab 162 mg/week subcutaneous from W0 to W51 (52 injections)

DRUG

Methotrexate treatment

"Methotrexate subcutaneous from W0 to W51 (52 administrations).~* W0: 7.5 mg/week~* W1: 0.2 mg/Kg/week~* W2 to W51: 0.3 mg/Kg/week (without exceeding 20 mg/week) Folic acid 10 mg/week, 48h after taking Methotrexate, from W0 to W51"

OTHER

Questionnaires

HAQ, SF-36, FACIT-fatigue

BIOLOGICAL

Blood samples

Additionnal blood samples for immunomonitoring

Trial Locations (1)

21079

CHU de Dijon, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER

NCT03892785 - MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | Biotech Hunter | Biotech Hunter