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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
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.
Time frame: Week 12
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.
Time frame: Baseline to Week 24
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.
Time frame: Baseline to Week 24
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.
Time frame: 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
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
Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up
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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
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.
Time frame: Baseline to Week 24
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.
Time frame: Baseline to Week 24