NCT01969019

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

3.8 years

First QC Date

October 21, 2013

Last Update Submit

October 21, 2013

Conditions

Graves' Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

  • response rate

    3 months

Secondary Outcomes (1)

  • change of CAS, adverse effects and retreat

    3 months

Study Arms (2)

methylprednisolone

ACTIVE COMPARATOR

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

Drug: methylprednisolone, prednisone

methylprednisolone plus prednisone

ACTIVE COMPARATOR

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

Interventions

methylprednisolone, prednisoneDRUG
methylprednisolonemethylprednisolone plus prednisone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Pregnant patient or patient who is planning to become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24606088DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

MethylprednisolonePrednisone

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Central Study Contacts

Ning Guang, Professor

CONTACT

(8621)64370045guangning@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 24, 2013

Study Start

January 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 24, 2013

Record last verified: 2013-10

Locations

CN(1)