A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy

Study Overview
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Brief Summary
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This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.

Official Title
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A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy

Conditions
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Graves' Ophthalmopathy

Intervention / Treatment
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* Drug: methylprednisolone, prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylprednisolone<br>intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks | Drug: methylprednisolone, prednisone<br> <br> |
| Active Comparator: methylprednisolone plus prednisone<br>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) | Drug: methylprednisolone, prednisone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of CAS, adverse effects and retreat |  | 3 months |