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

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT06927375
Phase
PHASE4
Status
Recruiting
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Conditions

  • Thyroid-Associated Ophthalmopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab(400mg) combined with Flupentixol Melitracen(0.5mg:10mg) — DRUG
    Tocilizumab (Actemra) is administered via intravenous infusion at a dose of 400 mg at Weeks 0, 4, and 8. Flupentixol/Melitracen is given orally at a dose of 0.5 mg/10 mg twice daily for 8 consecutive weeks starting from Week 0.
  • Tocilizumab(400mg) — DRUG
    Tocilizumab (Actemra) is administered via intravenous infusion at a dose of 400 mg at Weeks 0, 4, and 8.

Study Details

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).

Key Dates

Start date
Dec 12, 2024
Status verified
Apr 2025
Primary completion
Nov 12, 2025
Completion
Mar 12, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab combined with Flupentixol Melitracen
  • Active Comparator: Tocilizumab

Primary Outcome Measure

comprehensive score [ Time Frame: week12 ]

Central Contacts