Back to resultsA Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Primary Purpose
Graves' Ophthalmopathy
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
methylprednisolone, prednisone
Sponsored by
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
Arm Type
Active Comparator
Active Comparator
Arm Label
methylprednisolone
methylprednisolone plus prednisone
Arm Description
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)
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
change of CAS, adverse effects and retreat
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01969019
Brief Title
A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Official Title
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks
Arm Title
methylprednisolone plus prednisone
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
methylprednisolone, prednisone
Primary Outcome Measure Information:
Title
response rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change of CAS, adverse effects and retreat
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Guang, Professor
Phone
(8621)64370045
Ext
665344
Email
guangning@medmail.com.cn
Facility Information:
Facility Name
Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhu, Attending
Phone
(8621)64370045
Ext
602105
Email
juvey1515@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24606088
Citation
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.
Results Reference
derived
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A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
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