Actively Recruiting
Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
Led by Medical University of Warsaw · Updated on 2024-04-16
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Male or female aged 18 to 80 years
- Active and moderate-to-severe Graves' Orbitopathy diagnosed by guidelines with Clinical Activity Score 3
- Deterioration of disease in one or both eyes based on specific worsening criteria
- Incomplete response to intravenous methylprednisolone pulse therapy
- Euthyroid for at least 6-8 weeks with stable thyroid medication
- Negative pregnancy test for women of fertile age
- Use of reliable contraception for women of fertile age during study and six months after last dose
You will not qualify if you...
- Signs of sight-threatening thyroid eye disease (severe keratopathy, optic neuropathy)
- Pregnant, breastfeeding, or planning pregnancy during the study
- Need for radioactive iodine treatment or thyroidectomy during the study
- Prior treatment with any biological therapy
- Active infection or history of recurrent significant infections
- Positive tuberculosis test without treatment or documentation
- Recent infections requiring hospitalization or antibiotics
- History of intestinal ulceration or diverticulitis
- Chronic liver disease or elevated liver enzymes above 5 times normal
- Positive tests for hepatitis B, hepatitis C, or HIV without proper management
- Low neutrophil or platelet counts
- Elevated alkaline phosphatase or bilirubin levels beyond specified limits
- Significant cardiovascular or cerebrovascular disease
- Serious chronic illnesses including uncontrolled diabetes, kidney or lung disease, major depression
- History of sarcoidosis or immunodeficiency
- History of severe allergic reactions to monoclonal antibodies
- Recent live vaccinations within 30 days before or during treatment
- Splenectomy
- Current drug or alcohol abuse or dependence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Internal Medicine and Endocrinology, Medical University of Warsaw
Warsaw, Poland, 02-097
Actively Recruiting
Research Team
T
Tomasz Bednarczuk, MD, PHD
CONTACT
J
Joanna Rymuza, MD, PHD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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