Efficacy of Tocilizumab in association to steroids in giant cell arteritis with cerebro-vascular involvement patients (ToGiAS). A french prospective multicentre randomized versus placebo phase III trial (TOGIAC)

Conditions

Giant cell arteritis with Cerebro-vascular involvement

Brief summary

The primary endpoint is composite: complete remission of GCA with cerebrovascular involvement (clinical, biological, and PET uptake) including absence of clinical and MRI ischemic stroke recurrence at 24 weeks

Detailed description

Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Time to remission will be assessed at weeks 4, 12, 24 and 52, Serious adverse event-free survival will be assessed at weeks 4, 12, 24 and 52, Neurovascular imaging improvement: angio-CT improvement of vasculitis lesions and /or improvement or disappearance of PET FDG uptake will be assessed at weeks 4, 12, 24 and 52, Number and percentages of deaths Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Number and percentages of patients with rankin score 0-1 Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Percentage of clinical and MRI ischemic stroke recurrence at 24 weeks, Influence of tocilizumab treatment on cumulative steroid dose at 24 weeks, Safety of tocilizumab assessed by adverse events (mostly nasopharyngitis, headache, hypertension, injection site reactions and serious adverse events (mostly upper respiratory tract infections, but also rare liver damage), neutropenia and hypercholesterolemia

Related papers

No related papers found yet.

Interventions

DRUGTOCILIZUMAB

DRUGPlacebo of Tocilizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is composite: complete remission of GCA with cerebrovascular involvement (clinical, biological, and PET uptake) including absence of clinical and MRI ischemic stroke recurrence at 24 weeks	—

Secondary

Measure	Time frame
Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Time to remission will be assessed at weeks 4, 12, 24 and 52, Serious adverse event-free survival will be assessed at weeks 4, 12, 24 and 52, Neurovascular imaging improvement: angio-CT improvement of vasculitis lesions and /or improvement or disappearance of PET FDG uptake will be assessed at weeks 4, 12, 24 and 52, Number and percentages of deaths Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Number and percentages of patients with rankin score 0-1 Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Percentage of clinical and MRI ischemic stroke recurrence at 24 weeks, Influence of tocilizumab treatment on cumulative steroid dose at 24 weeks, Safety of tocilizumab assessed by adverse events (mostly nasopharyngitis, headache, hypertension, injection site reactions and serious adverse events (mostly upper respiratory tract infections, but also rare liver damage), neutropenia and hypercho	—

Measure

Time frame

Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Time to remission will be assessed at weeks 4, 12, 24 and 52, Serious adverse event-free survival will be assessed at weeks 4, 12, 24 and 52, Neurovascular imaging improvement: angio-CT improvement of vasculitis lesions and /or improvement or disappearance of PET FDG uptake will be assessed at weeks 4, 12, 24 and 52, Number and percentages of deaths Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Number and percentages of patients with rankin score 0-1 Relapse-free survival will be assessed at weeks 4, 12, 24 and 52, Percentage of clinical and MRI ischemic stroke recurrence at 24 weeks, Influence of tocilizumab treatment on cumulative steroid dose at 24 weeks, Safety of tocilizumab assessed by adverse events (mostly nasopharyngitis, headache, hypertension, injection site reactions and serious adverse events (mostly upper respiratory tract infections, but also rare liver damage), neutropenia and hypercho

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Countries

France

Outcome results

None listed