Graves'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with active and moderate, severe, sight threatening Graves' ophthalmopathy (GO). The activity of GO was assessed by CAS (more than 3 scores) or MRI.
Exclusion criteria
Exclusion criteria: Hepatitis B virus infection (carrier or HBcAb positive) Hepatitis C virus infection (HCVAb positive) Severe hypertension, heart disease, Psychiatric disease, HbA1c>8.0% Active tuberculosis Pregnancy Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: ophthalmological signs 1, 3, 6 and 12 months after pulse therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: CAS and MRI findings 1, 3, 6 and 12 months after pulse therapy. Safety: liver function test, glucose intolerance, peptic ulcer, psychiatric symptoms during and 1, 3, 6, 12 months after pulse therapy. | — |
Countries
Japan
Contacts
Kurume University Medical Center Division of Endocrinology and Metabolism