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

Graves' Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969019
• Other study ID #: CCEMD015
• Status: Recruiting
• Phase: Phase 4
• First received: October 21, 2013
• Last updated: October 21, 2013
• Start date: January 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Ruijin Hospital
• Contact: Ning Guang, Professor
• Phone: (8621)64370045
• Email: guangning[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Graves' Ophthalmopathy

Intervention

Drug:
• methylprednisolone, prednisone

Locations

Country	Name	City	State
China	Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		3 months	No
Secondary	change of CAS, adverse effects and retreat		3 months	Yes