MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. It is
characterized by a granulomatous inflammation of the wall of large vessels, involving
especially the aorta and extra-cranial branches of the external carotid, with vascular
remodelling leading to ischemic manifestations such as temporal headaches, jaw claudication,
scalp tenderness and visual loss. Most patients with GCA also present signs of systemic
inflammation, including weight loss, fatigue and fever, together with an increased
erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level.
Glucocorticoids (GC) are the cornerstone of the treatment of GCA. They are very effective and
are usually given for 18-24 months to avoid relapses. Therefore, most patients develop
GC-related complications that cause morbidity and disability. GC sparing strategies are thus
required to improve the treatment of GCA.
- A 12-month treatment with tocilizumab (TCZ) has recently been shown to be effective in
inducing and maintaining remission of GCA, with a dramatic GC-sparing effect. However,
TCZ is an expensive drug; TCZ suppresses CRP synthesis and ESR elevation so that it is
difficult to monitor patients; and importantly around 40% of patients relapse within 6
months after TCZ discontinuation, whether prescribed for 12 months or 4 months.
- In association with 6 months of prednisone, 10 mg/week of methotrexate (MTX) for 24
months lowers the risk of relapse at 24 months from 84% to 45%.
Therefore, the hypothesis is that 12 months of MTX treatment (0.3 mg/Kg/week, without
exceeding 20 mg/week) is not inferior to 12 months of TCZ (162 mg SC/week) in term of
prevention of relapse at 18 months. The MTX strategy might be more cost effective than TCZ.
In the present study, it is proposed to compare MTX versus TCZ in a multicenter randomized
controlled trial. Moreover, the economic consequences associated with the use of MTX rather
than TCZ will be also assess.