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

NCT ID: NCT01969019

Last Updated: 2013-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-10-31

Brief Summary

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

Conditions

Graves' Ophthalmopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

methylprednisolone

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

Group Type: ACTIVE_COMPARATOR

methylprednisolone, prednisone

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

methylprednisolone, prednisone

Intervention Type: DRUG

Interventions

methylprednisolone, prednisone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhu

Attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Guang, Professor

Role: CONTACT

guangning@medmail.com.cn

(8621)64370045 ext. 665344

Facility Contacts

Wei Zhu, Attending

Role: primary

juvey1515@gmail.com

(8621)64370045 ext. 602105

References

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.

Reference Type: DERIVED

PMID: 24606088 (View on PubMed)

Other Identifiers

CCEMD015

Identifier Type: -

Identifier Source: org_study_id