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

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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