Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04888221
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2021-03-25
Brief Title:
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement ToGiAC
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOGIAC
Brief Summary:
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
Detailed Description:
Giant cell arteritis GCA in the elderly is considered a medical emergency in case of ischemic complication urgent treatment is needed and high doses of intravenous steroids are used To date usual treatments added to steroids have not been shown to be effective in reducing the risk of ischemic event recurrence in GCA
Recently the efficacy of tocilizumab has been demonstrated as a steroid-sparing agent and a long-term complete remission agent The aim of this study is to address the potential benefits of tocilizumab as induction therapy in combination with high dose steroids to improve the neurovascular involvement in GCA
The study will enroll 66 subjects with GCA according to ACR criteria or positive temporal artery biopsy and neurovascular involvement symptomatic or asymptomatic It consist of a screening phase up to 30 days a baselinerandomization phase and a treatment phase with experimental treatment or placebo weekly administrated which could be combined with usual treatments for stroke as antiaggregants andor anticoagulants 24 weeks Regular visit will be performed to follow the GCA remission adverse treatments effects and proceed to radiological and biological evaluations visit assessment at weeks 2 4 8 12 16 20 24 28 32 36 until end of study visit at week 52
Recently the efficacy of tocilizumab has been demonstrated as a steroid-sparing agent and a long-term complete remission agent The aim of this study is to address the potential benefits of tocilizumab as induction therapy in combination with high dose steroids to improve the neurovascular involvement in GCA
The study will enroll 66 subjects with GCA according to ACR criteria or positive temporal artery biopsy and neurovascular involvement symptomatic or asymptomatic It consist of a screening phase up to 30 days a baselinerandomization phase and a treatment phase with experimental treatment or placebo weekly administrated which could be combined with usual treatments for stroke as antiaggregants andor anticoagulants 24 weeks Regular visit will be performed to follow the GCA remission adverse treatments effects and proceed to radiological and biological evaluations visit assessment at weeks 2 4 8 12 16 20 24 28 32 36 until end of study visit at week 52
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000080-23 | EUDRACT_NUMBER | None | None |