Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)

Sponsor
Medical University of Warsaw
Study ID
NCT06367517
Status
Completed

Conditions

  • Ophthalmopathy
  • Orbitopathy, Graves
  • Thyroid Eye Disease

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab administrated at a dose of 8 mg/kg, given once every four weeks

Study Details

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.

Key Dates

Start date
May 20, 2021
Status verified
Jun 2026
Primary completion
May 20, 2025
Completion
May 20, 2025

Study Design

Enrollment
32 participants (actual)

Arms

  • Arm: Graves' orbitopathy
    Patients with active, moderate to severe TED, without disease improvement after methylprednisolone pulse therapy in an intermediate-dose schedule (starting dose of 0.5 g once weekly for 6 weeks, followed by 0.25 g once weekly for 6 weeks) or high-dose regimens (a starting dose of 0.75 g once weekly for 6 weeks, followed by 0.5 g once weekly for 6 weeks) with or without concomitant radiotherapy.

Primary Outcome Measure

Disease improvement [ Time Frame: at 16, 24 and 48 weeks ]

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