Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04888221
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Giant Cell Arteritis
  • Neurovascular Disorder

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be administered subcutaneously at a dose of 162mg/0.9mL weekly (each week, on the same day) from week 0 to week 24. At the first injection (Baseline D0), a therapeutic education is provided for patients/caregivers who can carry out the injections themselves as part of their usual care.
  • Placebo — DRUG
    Placebo administered subcutaneously (SC) weekly during 24 weeks

Study Details

A French multicenter randomised and placebo-controlled study recruiting patients who present neurovascular involvement related to GCA (\> 60 years) with symptomatic (stroke) or asymptomatic forms. The aim of this study is to assess the efficacy of tocilizumab to induce complete remission of GCA with cerebrovascular involvement (clinical and biological) and absence of clinical and MRI ischemic stroke recurrence at 24 weeks.

Key Dates

Start date
Sep 24, 2021
Status verified
Jun 2025
Primary completion
Jan 29, 2025
Completion
Aug 13, 2025

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks
    Tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks
  • Placebo Comparator: placebo administered subcutaneously (SC) weekly during 24 weeks
    Placebo administered subcutaneously (SC) weekly during 24 weeks

Primary Outcome Measure

Percentage of patients in complete remission of GCA with absence of ischemic stroke recurrence at 24 weeks under tocilizumab. [ Time Frame: From date of treatment initiation until 24 weeks. ]

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