NCT03892785: METOGiA

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

Active, enrolled Phase 3 Last updated 21 April 2026

What this trial tests

Phase 3 trial testing Prednisone treatment in Giant Cell Arteritis in 230 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 January 2020

Primary endpoint
1 January 2027

1 January 2027

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	230
Start date	27 January 2020
Primary completion	1 January 2027
Estimated completion	1 January 2027
Sites	1 location across France

Drugs / interventions tested

• Prednisone treatment — full drug profile →
• Tocilizumab treatment — full drug profile →
• Methotrexate treatment — full drug profile →
• Questionnaires
• Blood samples — full drug profile →

Conditions studied

• Giant Cell Arteritis — all drugs for Giant Cell Arteritis →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

50 and older, any sex, with Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of patients alive without relapse after initial remission or deviation from the scheduled regimen of prednisone
  Time frame: Week 78

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in the Treatment of Giant Cell Arteritis.
   Castañeda S, Prieto-Peña D, Vicente-Rabaneda EF, Triguero-Martínez A, et al · · 2022 · cited 27× · PMID 35329914 · DOI 10.3390/jcm11061588
2. Treatment of Giant Cell Arteritis and Takayasu Arteritis-Current and Future.
   Hellmich B, Águeda AF, Monti S, Luqmani R. · · 2020 · cited 22× · PMID 33044642 · DOI 10.1007/s11926-020-00964-x
3. Reducing the Toxicity of Long-Term Glucocorticoid Treatment in Large Vessel Vasculitis.
   Palmowski A, Buttgereit F. · · 2020 · cited 17× · PMID 33047263 · DOI 10.1007/s11926-020-00961-0
4. Treatment of Giant Cell Arteritis (GCA).
   Régent A, Mouthon L. · · 2022 · cited 10× · PMID 35407411 · DOI 10.3390/jcm11071799
5. Temporal Artery Vascular Diseases.
   Greigert H, Ramon A, Tarris G, Martin L, et al · · 2022 · cited 10× · PMID 35012016 · DOI 10.3390/jcm11010275
6. Tocilizumab for giant cell arteritis.
   Antonio AA, Santos RN, Abariga SA. · · 2022 · cited 9× · PMID 35560150 · DOI 10.1002/14651858.cd013484.pub3
7. Tocilizumab for giant cell arteritis.
   Antonio AA, Santos RN, Abariga SA. · · 2021 · cited 6× · PMID 34420204 · DOI 10.1002/14651858.cd013484.pub2
8. Current developments in the diagnosis and treatment of giant cell arteritis.
   Szekeres D, Al Othman B. · · 2022 · cited 5× · PMID 36582285 · DOI 10.3389/fmed.2022.1066503