99Tc-MDP for Thyroid-Associated Ophthalmopathy
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|ClinicalTrials.gov Identifier: NCT03948191|
Recruitment Status : Completed
First Posted : May 13, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thyroid-Associated Ophthalmopathy||Drug: Methylprednisolone Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||March 31, 2019|
Active Comparator: Methylprednisolone(ivMP)
Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
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.
Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Other Name: Yunke
- Responder Status at Week 12 [ Time Frame: 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.
- Overall Average Continuous Change in CAS From Baseline to Week 24 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline 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 [ Time Frame: Baseline to Week 24 ]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 [ Time Frame: Baseline to Week 24 ]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 [ Time Frame: Baseline to Week 24 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948191
|Affiliated Zhongshan Hospital of Dalian University|
|Dalian, Liaoning, China, 116001|