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

Phase 4

• Conditions: Graves' Ophthalmopathy
• Interventions: Drug: methylprednisolone, prednisone

• Registration Number: NCT01969019
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Last Update Submitted: 2013-10-21
• Study First Posted: 2013-10-24
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone plus prednisone	methylprednisolone, 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	methylprednisolone, prednisone	intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks

Primary Outcome Measures

Name	Time	Method
response rate	3 months

Secondary Outcome Measures

Name	Time	Method
change of CAS, adverse effects and retreat	3 months

Trial Locations

Locations (1)

Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China