Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03892785
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2019-03-26
Brief Title:
MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis a Multicenter Randomized Controlled Trial
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis a Multicenter Randomized Controlled Trial
Status:
ACTIVE_NOT_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:
METOGiA
Brief Summary:
Giant-cell arteritis GCA is the most frequent vasculitis after 50 years It is characterized by a granulomatous inflammation of the wall of large vessels involving especially the aorta and extra-cranial branches of the external carotid with vascular remodelling leading to ischemic manifestations such as temporal headaches jaw claudication scalp tenderness and visual loss Most patients with GCA also present signs of systemic inflammation including weight loss fatigue and fever together with an increased erythrocyte sedimentation rate ESR and C-reactive protein CRP level
Glucocorticoids GC are the cornerstone of the treatment of GCA They are very effective and are usually given for 18-24 months to avoid relapses Therefore most patients develop GC-related complications that cause morbidity and disability GC sparing strategies are thus required to improve the treatment of GCA
A 12-month treatment with tocilizumab TCZ has recently been shown to be effective in inducing and maintaining remission of GCA with a dramatic GC-sparing effect However TCZ is an expensive drug TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients and importantly around 40 of patients relapse within 6 months after TCZ discontinuation whether prescribed for 12 months or 4 months
In association with 6 months of prednisone 10 mgweek of methotrexate MTX for 24 months lowers the risk of relapse at 24 months from 84 to 45
Therefore the hypothesis is that 12 months of MTX treatment 03 mgKgweek without exceeding 20 mgweek is not inferior to 12 months of TCZ 162 mg SCweek in term of prevention of relapse at 18 months The MTX strategy might be more cost effective than TCZ
In the present study it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial Moreover the economic consequences associated with the use of MTX rather than TCZ will be also assess
Glucocorticoids GC are the cornerstone of the treatment of GCA They are very effective and are usually given for 18-24 months to avoid relapses Therefore most patients develop GC-related complications that cause morbidity and disability GC sparing strategies are thus required to improve the treatment of GCA
A 12-month treatment with tocilizumab TCZ has recently been shown to be effective in inducing and maintaining remission of GCA with a dramatic GC-sparing effect However TCZ is an expensive drug TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients and importantly around 40 of patients relapse within 6 months after TCZ discontinuation whether prescribed for 12 months or 4 months
In association with 6 months of prednisone 10 mgweek of methotrexate MTX for 24 months lowers the risk of relapse at 24 months from 84 to 45
Therefore the hypothesis is that 12 months of MTX treatment 03 mgKgweek without exceeding 20 mgweek is not inferior to 12 months of TCZ 162 mg SCweek in term of prevention of relapse at 18 months The MTX strategy might be more cost effective than TCZ
In the present study it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial Moreover the economic consequences associated with the use of MTX rather than TCZ will be also assess
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?:
None
Is an FDA AA801 Violation?:
None