Graves' Ophthalmopathy
Conditions
Brief summary
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.
Interventions
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients should meet the criteria of either a or b and together with c, d and e to include into the study. a. Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis iii) Optic nerve involvement iv) Extraocular muscle involvement b. Thyroid dysfunction with any one of the following: i) Proptosis ii) Optic nerve involvement iii) Extraocular muscle involvement c. Exclude cases with such ophthalmological signs caused by other diseases. d. Moderate to severe patients defined by EUGOGO. e. Clinical activity score (CAS)≥3/7 f. Normal function of heart, liver and kidney.
Exclusion criteria
* Orbital decompression surgery needed immediately * History of chronic recurrent or active infection * History of peptic ulcer * Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal * History of HIV, hepatitis C or hepatitis B Positive * Cardiovascular or cerebrovascular disease clinically significant * Uncontrolled diabetes mellitus * Use of corticosteroids during 12 weeks before to inclusion period * Pregnant patient or patient who is planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| change of CAS, adverse effects and retreat | 3 months |
Countries
China
Contacts
Primary ContactNing Guang, Professor
Outcome results
None listed