Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01450137
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2011-10-03
Brief Title:
Tocilizumab for Patients With Giant Cell Arteritis
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo Controlled Study of Tocilizumab in Patients With Giant Cell Arteritis
Status:
COMPLETED
Status Verified Date:
2018-09
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:
None
Brief Summary:
Giant-cell arteritis GCA is an immune-mediated disease that mostly affects people older than 50 years of age Glucocorticoid GC treatment dramatically alters the symptoms and course of GCA reducing the likelihood of vascular complications that could lead eg to blindness However relapses usually occur when GC dosages are tapered resulting in frequent re-treatment with high cumulative dosages of GC over time with substantial toxicity and morbidity eg diabetes mellitus infections enhanced cardiovascular risk osteoporotic fractures cataracts
Therefore novel therapies are needed that effectively reduce the dose and duration of GC treatment and provide more durable remissions of GCA
Tocilizumab TCZ is a humanized monoclonal antibody directed against the human interleukin-6 receptor IL-6R Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis Inhibition of IL-6 andor its receptor therefore represents a new and novel approach for the treatment of RA
The primary endpoint is the proportion of patients that have achieved complete remission of disease after treatment with TCZ compared to treatment with placebo at week 12 All patients will receive glucocorticoids in a standardized form
Therefore novel therapies are needed that effectively reduce the dose and duration of GC treatment and provide more durable remissions of GCA
Tocilizumab TCZ is a humanized monoclonal antibody directed against the human interleukin-6 receptor IL-6R Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis Inhibition of IL-6 andor its receptor therefore represents a new and novel approach for the treatment of RA
The primary endpoint is the proportion of patients that have achieved complete remission of disease after treatment with TCZ compared to treatment with placebo at week 12 All patients will receive glucocorticoids in a standardized form
Detailed Description:
Background
Giant-cell arteritis GCA is an immune-mediated disease that mostly affects people older than 50 years of age Glucocorticoid GC treatment dramatically alters the symptoms and course of GCA reducing the likelihood of vascular complications that could lead eg to blindness However relapses usually occur when GC dosages are tapered resulting in frequent re-treatment with high cumulative dosages of GC over time with substantial toxicity and morbidity eg diabetes mellitus infections enhanced cardiovascular risk osteoporotic fractures cataracts
Therefore novel therapies are needed that effectively reduce the dose and duration of GC treatment and provide more durable remissions of GCA
Tocilizumab TCZ is a humanized monoclonal antibody directed against the human interleukin-6 receptor IL-6R Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis Inhibition of IL-6 andor its receptor therefore represents a new and novel approach for the treatment of RA
Objective
The primary endpoint is the proportion of patients that have achieved complete remission of disease normal ESR and CRP absence of signs and symptoms at Week 12 at a GC dose of 01 mgkgd of prednisone
Methods
2-arm Tocilizumab Glucocorticoids GCs vs Placebo GCs randomized placebo-controlled double blind monocentric trial in patients with newly onset or relapsing giant cell arteritis GCA satisfying ACR criteria AND an elevated sedimentation rate above 40 mmh and a CRP 20 mgL AND a biopsy proven GCA OR a large vessel vasculitis assessed by MR Angiography MRA
Giant-cell arteritis GCA is an immune-mediated disease that mostly affects people older than 50 years of age Glucocorticoid GC treatment dramatically alters the symptoms and course of GCA reducing the likelihood of vascular complications that could lead eg to blindness However relapses usually occur when GC dosages are tapered resulting in frequent re-treatment with high cumulative dosages of GC over time with substantial toxicity and morbidity eg diabetes mellitus infections enhanced cardiovascular risk osteoporotic fractures cataracts
Therefore novel therapies are needed that effectively reduce the dose and duration of GC treatment and provide more durable remissions of GCA
Tocilizumab TCZ is a humanized monoclonal antibody directed against the human interleukin-6 receptor IL-6R Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis Inhibition of IL-6 andor its receptor therefore represents a new and novel approach for the treatment of RA
Objective
The primary endpoint is the proportion of patients that have achieved complete remission of disease normal ESR and CRP absence of signs and symptoms at Week 12 at a GC dose of 01 mgkgd of prednisone
Methods
2-arm Tocilizumab Glucocorticoids GCs vs Placebo GCs randomized placebo-controlled double blind monocentric trial in patients with newly onset or relapsing giant cell arteritis GCA satisfying ACR criteria AND an elevated sedimentation rate above 40 mmh and a CRP 20 mgL AND a biopsy proven GCA OR a large vessel vasculitis assessed by MR Angiography MRA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None