Thyroid-Associated OphthalmopathyPhase 4NCT03948191
99Tc-MDP for Thyroid-Associated Ophthalmopathy
A Phase 4 study testing Methylprednisolone and 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) in people with Thyroid-Associated Ophthalmopathy, run by Dalian University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Thyroid-Associated Ophthalmopathy
- What is being tested?
- Methylprednisolone and 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2017to 31 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Optic neuropathy, severe orbital appearance and surgical;
- Extra-thyroid disease;
- Pregnant and children;
- Severe impairment of cardiac, hepatic and renal functions;
- Allergies;
- Other contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
About this study
Official title: A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
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.
- Conditions
- Thyroid-Associated Ophthalmopathy
- Being tested
- Methylprednisolone, 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
- Keywords
- 99Tc-MDP, TAO, efficacy, safety
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
99Tc-MDP(99Technetium-Methylenediphosphonate Injection)Drug
Also called Yunke
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start16 Oct 2017
- Primary completion30 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid-Associated OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948191
- Sponsor's protocol ID
- zsyy_nfm2-2017-10
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
- ClinicalTrials.gov ID
- NCT03948191
- Acronym / sponsor ID
- zsyy_nfm2-2017-10
- Conditions
- Thyroid-Associated Ophthalmopathy
- Keywords
- 99Tc-MDP, TAO, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dalian UniversityUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone(ivMP) | Active comparator | Drug: MethylprednisoloneMethylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks. |
| 99Tc-MDP | Experimental | Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Optic neuropathy, severe orbital appearance and surgical;
- Extra-thyroid disease;
- Pregnant and children;
- Severe impairment of cardiac, hepatic and renal functions;
- Allergies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks. | Drug | Methylprednisolone(ivMP) |
| 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)Also: Yunke15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions. | Drug | 99Tc-MDP |
Primary outcome
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.
7 secondary outcomes
Overall Average Continuous Change in CAS From Baseline to Week 24
Time frame: Baseline to Week 24
Overall Average Continuous Change in Proptosis From Baseline to Week 24
Time frame: Baseline to Week 24
Overall Average Change in Diplopia grading From Baseline to Week 24
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
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
Time frame: Baseline to Week 24
Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up
Time frame: Baseline to Week 24
Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up
Time frame: Baseline to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone and 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) in people with Thyroid-Associated Ophthalmopathy, run by Dalian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Status at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.