Thyroid Eye Disease Clinical Trial
Official title:
Efficacy and Safety of Tocilizumab in Patients With Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease: Open, Prospective, Observational Study
The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04583735 -
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
|
Phase 4 | |
| Active, not recruiting |
NCT05002998 -
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
|
Phase 4 | |
| Withdrawn |
NCT02422368 -
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT03298867 -
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
|
Phase 3 | |
| Recruiting |
NCT05987423 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
|
Phase 3 | |
| Recruiting |
NCT06112340 -
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05517447 -
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
|
Phase 3 | |
| Terminated |
NCT04737330 -
A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
|
Phase 3 | |
| Recruiting |
NCT05517421 -
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
|
Phase 3 | |
| Recruiting |
NCT04311606 -
Anti-VEGF Therapy for Acute Thyroid Eye Disease
|
Phase 2 | |
| Recruiting |
NCT06106828 -
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)
|
Phase 3 | |
| Recruiting |
NCT06021054 -
A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
|
Phase 3 | |
| Not yet recruiting |
NCT06413043 -
Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy
|
N/A | |
| Not yet recruiting |
NCT06401044 -
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
|
Phase 1 | |
| Recruiting |
NCT06384547 -
A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
|
Phase 3 | |
| Recruiting |
NCT06275373 -
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
|
||
| Enrolling by invitation |
NCT05241626 -
AS-OCT of the Cornea in Thyroid Diseases
|
||
| Active, not recruiting |
NCT05776121 -
Study of ZB001 in Chinese Patients With Thyroid Eye Disease
|
Phase 1 | |
| Recruiting |
NCT04359979 -
Tamsulosin for Thyroid Lid Retraction
|
N/A | |
| Recruiting |
NCT06226545 -
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
|
Phase 2 |