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A 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
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves' Ophthalmopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 21, 2013
Last Updated
October 21, 2013
Sponsor
Ruijin Hospital
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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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