A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
NCT ID: NCT01969019
Last Updated: 2013-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2010-01-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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methylprednisolone
intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks
methylprednisolone, prednisone
methylprednisolone plus prednisone
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)
methylprednisolone, prednisone
Interventions
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methylprednisolone, prednisone
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Wei Zhu
Attending
Locations
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Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Zhu, Attending
Role: primary
References
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Zhu W, Ye L, Shen L, Jiao Q, Huang F, Han R, Zhang X, Wang S, Wang W, Ning G. A prospective, randomized trial of intravenous glucocorticoids therapy with different protocols for patients with graves' ophthalmopathy. J Clin Endocrinol Metab. 2014 Jun;99(6):1999-2007. doi: 10.1210/jc.2013-3919. Epub 2014 Feb 28.
Other Identifiers
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CCEMD015
Identifier Type: -
Identifier Source: org_study_id