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

Sponsor

Ruijin Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01969019

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graves' Ophthalmopathy	Drug: methylprednisolone, prednisone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: methylprednisolone intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks	Drug: methylprednisolone, prednisone
Active Comparator: 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)	Drug: methylprednisolone, prednisone

Arm

Intervention/Treatment

Active Comparator: methylprednisolone

intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks

Drug: methylprednisolone, prednisone

Active Comparator: 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)

Drug: methylprednisolone, prednisone

Outcome Measures

Primary Outcome Measures

response rate [3 months]

Secondary Outcome Measures

change of CAS, adverse effects and retreat [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis

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