A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Graves' Ophthalmopathy
About this trial
This is an interventional treatment trial for Graves' Ophthalmopathy
Eligibility Criteria
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
Sites / Locations
- Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
methylprednisolone
methylprednisolone plus prednisone
intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks
intravenous MP 0.5g daily for three days per week, twice, followed by 0.25g daily for three days per week, twice, and followed by tapering oral prednisone (starting with 60mg/d, then10 mg less/week than each previous week for the next 3 weeks, then20mg/week at the 5th week followed with 5mg less/week than each previous week for the next 3 weeks)