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

Study acronym: METOGiA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2026 to Jan 2027 Completion date: Mar 2027 to Jan 2027v15 Show 1 more changeShow less
    • Completion date: Mar 2027 to Jan 2027
  2. 3 versions Re-verified since Dec 31, 2024, no change to tracked fieldsv12-v14
  3. Trial status: Recruiting to Active, Not Recruiting Site details revisedv11 Show 1 more changeShow less
    • Site details revised
  4. 2 versions Re-verified since Dec 16, 2022, no change to tracked fieldsv9-v10
  5. Primary completion date: Jan 2025 to Jan 2026 Enrollment target: 200 to 230 · Completion date: Mar 2026 to Mar 2027v8 Show 2 more changesShow less
    • Enrollment target: 200 to 230
    • Completion date: Mar 2026 to Mar 2027
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Primary endpoint revised Eligibility criteria expanded, about 12 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Eligibility criteria expanded, about 6 wordsv4 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2025 to Jan 2025 · Completion date: Dec 2025 to Mar 2026 · Start date changed from estimate of Oct 2019 to Jan 27, 2020 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Oct 2025 to Jan 2025
    • Completion date: Dec 2025 to Mar 2026
    • Start date changed from estimate of Oct 2019 to Jan 27, 2020
    • Site details revised
  6. Start date: May 2019 to Oct 2019 Primary completion date: May 2025 to Oct 2025 · Completion date: Sep 2025 to Dec 2025v2 Show 2 more changesShow less
    • Primary completion date: May 2025 to Oct 2025
    • Completion date: Sep 2025 to Dec 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03892785
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Giant Cell Arteritis
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov