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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Graves' Ophthalmopathy

Treatments: Drug: methylprednisolone, prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01969019

CCEMD015

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: methylprednisolone, prednisone

methylprednisolone plus prednisone

Active Comparator group

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)

Treatment:

Drug: methylprednisolone, prednisone