NCT03948191

Brief Summary

To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

October 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

May 10, 2019

Last Update Submit

May 13, 2019

Conditions

Thyroid-Associated Ophthalmopathy

Keywords

99Tc-MDPTAOefficacysafety

Outcome Measures

Primary Outcomes (1)

  • Responder Status at Week 12

    This end point main evaluation improvement of clinical activity score and proptosis at week 12. A reduction of the CAS 2 point or more, and reduction of the proptosis 2 mm or more was defined as response.

    Week 12

Secondary Outcomes (7)

  • Overall Average Continuous Change in CAS From Baseline to Week 24

    Baseline to Week 24

  • Overall Average Continuous Change in Proptosis From Baseline to Week 24

    Baseline to Week 24

  • Overall Average Change in Diplopia grading From Baseline to Week 24

    Baseline to Week 24

  • Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24

    Baseline to Week 24

  • Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up

    Baseline to Week 24

  • +2 more secondary outcomes

Study Arms (2)

Methylprednisolone(ivMP)

ACTIVE COMPARATOR

Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Drug: Methylprednisolone

99Tc-MDP

EXPERIMENTAL

99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)

Interventions

MethylprednisoloneDRUG

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Methylprednisolone(ivMP)
99Tc-MDP(99Technetium-Methylenediphosphonate Injection)DRUG

15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Also known as: Yunke
99Tc-MDP

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient age 18 Years to 76 Years;
  • Fewer than 6 months from onset of TAO;
  • Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
  • Moderate to severe TAO;
  • No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

You may not qualify if:

  • Optic neuropathy, severe orbital appearance and surgical;
  • Extra-thyroid disease;
  • Pregnant and children;
  • Severe impairment of cardiac, hepatic and renal functions;
  • Allergies;
  • Other contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Methylprednisolone

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 Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 13, 2019

Study Start

October 16, 2017

Primary Completion

December 30, 2018

Study Completion

March 31, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

CN(1)