Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03745586
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2018-11-06
Brief Title:
Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab
Status:
COMPLETED
Status Verified Date:
2021-06
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:
GUSTO
Brief Summary:
Two recent RCTs showed the ability of tocilizumab to induce and maintain remission of giant cell arteritis Both studies used the dosing schemes for Rheumatoid Arthritis ie 8mgkg bodyweight iv in 4-weekly intervals and 162mg weekly sc respectively In both trials glucocorticoids GC were initially administrated at medium to high doses with subsequent rapid reduction and discontinuation over 24 weeks In case of relapse GC doses were re-increased
The results of both studies suggest that GC could be reduced more rapidly This would further reduce GC-induced adverse effects
Thus the investigators propose to perform an open label single arm study to assess the efficacy of ultra-short co-medication with GC using Simons minimax two-stage design
The results of both studies suggest that GC could be reduced more rapidly This would further reduce GC-induced adverse effects
Thus the investigators propose to perform an open label single arm study to assess the efficacy of ultra-short co-medication with GC using Simons minimax two-stage design
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None