Study of Tocilizumab and Flupentixol-Melitracen Combination for Treating Moderate to Severe Thyroid-Associated Eye Disease

What this Trial Is About

Thyroid-associated ophthalmopathy TAO is a serious autoimmune condition that can threaten vision and is categorized into mild, moderate, and severe stages. This trial focuses on patients with moderate to severe active TAO, a form that is difficult to treat and often resistant to first-line therapies such as intravenous glucocorticoids. The study evaluates the impact of adding Flupentixol Melitracen, a drug aimed at reducing anxiety and depression, to Tocilizumab treatment, which is a second-line therapy targeting immune system activity. Participants receive either Tocilizumab alone or Tocilizumab combined with Flupentixol Melitracen. Tocilizumab is given by intravenous infusion at 400 mg at weeks 0, 4, and 8. Flupentixol Melitracen is taken orally twice daily for 8 weeks, starting at week 0. This randomized controlled trial compares the effects of these treatments over a 12-week period to assess their influence on both eye disease activity and psychological symptoms. During the study, participants will be monitored through comprehensive assessments including the Clinical Activity Score CAS, quality of life questionnaires specific to thyroid eye disease, and evaluations of eye symptoms such as diplopia and proptosis. Researchers will measure changes in these scores at 12 weeks to determine the treatments impact. The study includes safety monitoring and aims to improve both ocular outcomes and emotional well-being in patients with refractory TAO.

A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy