Efficacy and Safety of Tocilizumab in Patients With Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease: Open, Prospective, Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Written informed consent

• Male or female, 18-80 years old

• Patients with active (Clinical Activity Score ≥ 3 in 7-item scale) and moderate-to-severe GO, diagnosed according to the EUGOGO guidelines, after the completion of MP pulse treatment, WITH

• o Deterioration of GO (in 1 or 2 eyes) when two of the following occurred:

• increase in palpebral aperture by at least 2 mm;

• deterioration in CAS by at least 2 points (7-point CAS)

• increase in exophthalmos by at least 2 mm;

• worsening of diplopia (appearance or change in the degree)

• worsening in ocular motility by 8o

• o Incomplete response in both eyes to intravenous methylprednisolone pulse therapy; defined changes smaller than previously defined in any of the mentioned parameters.

• Euthyroid for at least 6-8 weeks (serum free hormone concentrations within 30% of normal range) on either anti-thyroid medications (tyonamides) to control hyperthyroidism or L-thyroxine for replacement therapy for hypothyroidism.

• Negative pregnancy test in women of fertile age.

• All female patients of fertile age must use a reliable contraceptive method to prevent pregnancy during the study period, and at least during a period of six months following the last dose of the investigational medicinal product.

Locations
Other Locations
Poland
Department of Internal Medicine and Endocrinology, Medical University of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Tomasz Bednarczuk, MD, PHD
tomasz.bednarczuk@wum.edu.pl
48225992975
Backup
Joanna Rymuza, MD, PHD
joanna.rymuza@wum.edu.pl
48225992975
Time Frame
Start Date: 2021-05-20
Estimated Completion Date: 2026-05-20
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov

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