drugset / Trial / NCT06927375
A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
Phase 4
Recruiting
60 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
RandomizedParallel-groupSingle-blindTreatment
Summary
Thyroid-associated ophthalmopathy (TAO) is a serious, progressive, vision-threatening autoimmune disease that can be categorized into mild, moderate, and severe stages based on severity. The activity of TAO is commonly evaluated using the Clinical Activity Score (CAS). Tocilizumab serves as a second-line treatment option for patients with moderate to severe active TAO. Additionally, it is common for TAO patients to experience anxiety, which may exacerbate their condition and negatively impact prognosis. Therefore, we have designed this randomized controlled study to evaluate the impact of Flupentixol Melitracen (Lepan) on the treatment outcomes of participants receiving Tocilizumab (Actemra).
Timeline
- Start
- 2024-12-12
- Primary completion
- 2025-11-12
- Completion
- 2026-03-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flupentixol | Unknown | 0.5 mg | Oral |
| Subject | Melitracen | Small molecule | 10 mg | Oral |
| Subject | Tocilizumab | Monoclonal antibody | 400 mg | Intravenous |