Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367517
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-27
Brief Title:
Tocilizumab in Corticosteroid-Resistant Graves Orbitopathy Thyroid Eye Disease
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Efficacy and Safety of Tocilizumab in Patients With Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease Open Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The aim of this study is to evaluate the efficacy and safety of Tocilizumab as secondthird line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease
Detailed Description:
Graves Orbitopathy GO is an autoimmune disease that involves orbital tissues leading to temporary or permanent damage to the eye Although GO is a rare condition it negatively affects the quality of life in the majority of patients In the majority of european centers high-dose intravenous glucocorticoid GCs therapy remains the first-line treatment in patients with active moderate-to-severe GO However GCs are effective in only 45-60 of patients with a high probability of diseases relapse 10-40 or disease progression to dysthyroid optic neuropathy up to 10 Due to limited efficacy of GCs unpredictable relapses and progression of GO the management of GO remains a challenge
A few studies have demonstrated that interleukin-6 IL-6 blockade with tocilizumab TCZ is effective in GC-refractory GO However the long-term outcomes of TCZ remain scarce
Therefore the investigators are planning to assess the therapy with Tocilizumab regarding clinical outcomes and adverse events The investigators plan to include a total of 30 patients with active moderate-to-severe corticosteroid-resistant GO over a period of approximately 4 years
A few studies have demonstrated that interleukin-6 IL-6 blockade with tocilizumab TCZ is effective in GC-refractory GO However the long-term outcomes of TCZ remain scarce
Therefore the investigators are planning to assess the therapy with Tocilizumab regarding clinical outcomes and adverse events The investigators plan to include a total of 30 patients with active moderate-to-severe corticosteroid-resistant GO over a period of approximately 4 years
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