Actively Recruiting
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
Led by The First Affiliated Hospital of Xiamen University · Updated on 2026-04-29
8
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects. This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.
CONDITIONS
Official Title
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Clinical diagnosis of Graves' orbitopathy according to EUGOGO criteria
- Moderate-to-severe disease impacting daily life but not threatening sight
- Active disease with a Clinical Activity Score of 3 or higher
- Glucocorticoid-resistant (no improvement after at least 3g intravenous methylprednisolone) or glucocorticoid-intolerant (contraindications or severe side effects)
- Stable thyroid function on antithyroid or thyroxine therapy for at least 4 weeks
- Women of childbearing potential must use effective contraception during and 4 weeks after treatment
- Able and willing to provide informed consent and follow study procedures
You will not qualify if you...
- Sight-threatening disease such as dysthyroid optic neuropathy or severe corneal damage needing urgent surgery
- Fibrotic or inactive stage of disease with Clinical Activity Score less than 3
- Prior orbital radiotherapy or surgical decompression at any time
- Eye muscle or eyelid surgery within 3 months before baseline
- Use of other biologic immunomodulators within 3 months before baseline
- Active or untreated infections including tuberculosis, hepatitis B or C, HIV, or recent severe infections requiring hospitalization
- History of blood clots or known blood clotting disorders
- History of any cancer within the past 5 years except certain skin or cervical cancers
- Blood counts or liver and kidney function outside safe limits as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
F
Fangsen Xiao, MD
CONTACT
L
Liyin Wang, MM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here