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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by Ruijin Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Wei Zhu, Ruijin Hospital
ClinicalTrials.gov Identifier:
First received: October 21, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.

Condition Intervention Phase
Graves' Ophthalmopathy
Drug: methylprednisolone, prednisone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy

Resource links provided by NLM:

Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of CAS, adverse effects and retreat [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969019

Contact: Ning Guang, Professor (8621)64370045 ext 665344 guangning@medmail.com.cn

China, Shanghai
Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Wei Zhu, Attending    (8621)64370045 ext 602105    juvey1515@gmail.com   
Sponsors and Collaborators
Ruijin Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Zhu, Attending, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01969019     History of Changes
Other Study ID Numbers: CCEMD015 
Study First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Autoimmune Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Immune System Diseases
Orbital Diseases
Thyroid Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 30, 2016