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99Tc-MDP for Thyroid-Associated Ophthalmopathy

Primary Purpose

Thyroid-Associated Ophthalmopathy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone
99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
Sponsored by
Dalian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid-Associated Ophthalmopathy focused on measuring 99Tc-MDP, TAO, efficacy, safety

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Affiliated Zhongshan Hospital of Dalian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Methylprednisolone(ivMP)

99Tc-MDP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Average Continuous Change in CAS From Baseline to Week 24
The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. CAS of 3 point or more on a 7-point scale indicating active thyroid-associated ophthalmopathy.
Overall Average Continuous Change in Proptosis From Baseline to Week 24
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.
Overall Average Change in Diplopia grading From Baseline to Week 24
Diplopia grading included 01/4no：no diplopia; 11/4intermittent： diplopia in primary position of gaze, when tired or when first awakening; 21/4inconstant： diplopia at extremes of gaze; 31/4constant： continuous diplopia in primary or reading position). Diplopia change in one grade or more at week 24 was regarded as improvement.
Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24
Observation of extra-ocular muscular thickening is observed on Orbital CT. One or more extra-ocular muscle recovery at week 24 was regarded as improvemed.
Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid associated ophthalmopathy (TAO) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale.The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health). A change of 8 point was defined as improvement.
Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up
Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 50 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.
Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up
Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 50 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.

Full Information

First Posted
May 10, 2019
Last Updated
May 13, 2019
Sponsor
Dalian University
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1. Study Identification

Unique Protocol Identification Number
NCT03948191
Brief Title
99Tc-MDP for Thyroid-Associated Ophthalmopathy
Official Title
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-Associated Ophthalmopathy
Keywords
99Tc-MDP, TAO, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone(ivMP)
Arm Type
Active Comparator
Arm Description
Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
Arm Title
99Tc-MDP
Arm Type
Experimental
Arm Description
99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
Other Intervention Name(s)
Yunke
Intervention Description
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Primary Outcome Measure Information:
Title
Responder Status at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Overall Average Continuous Change in CAS From Baseline to Week 24
Description
The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. CAS of 3 point or more on a 7-point scale indicating active thyroid-associated ophthalmopathy.
Time Frame
Baseline to Week 24
Title
Overall Average Continuous Change in Proptosis From Baseline to Week 24
Description
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.
Time Frame
Baseline to Week 24
Title
Overall Average Change in Diplopia grading From Baseline to Week 24
Description
Diplopia grading included 01/4no：no diplopia; 11/4intermittent： diplopia in primary position of gaze, when tired or when first awakening; 21/4inconstant： diplopia at extremes of gaze; 31/4constant： continuous diplopia in primary or reading position). Diplopia change in one grade or more at week 24 was regarded as improvement.
Time Frame
Baseline to Week 24
Title
Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24
Description
Observation of extra-ocular muscular thickening is observed on Orbital CT. One or more extra-ocular muscle recovery at week 24 was regarded as improvemed.
Time Frame
Baseline to Week 24
Title
Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up
Description
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid associated ophthalmopathy (TAO) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale.The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health). A change of 8 point was defined as improvement.
Time Frame
Baseline to Week 24
Title
Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up
Description
Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 50 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.
Time Frame
Baseline to Week 24
Title
Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up
Description
Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 50 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Optic neuropathy, severe orbital appearance and surgical; Extra-thyroid disease; Pregnant and children; Severe impairment of cardiac, hepatic and renal functions; Allergies; Other contraindications.
Facility Information:
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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99Tc-MDP for Thyroid-Associated Ophthalmopathy

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