Trial · NCT04737330
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plan A - Percentage of Participants Achieving Overall Response | Baseline, Week 16 | The percentage of participants achieving overall response was defined as follows: \>= 2 points reduction in clinical activity score (CAS) AND \>= 2 mm reduction in proptosis from Baseline in the study eye, provided there was no corresponding deterioration in CAS or proptosis (\>= 2 point or 2 mm increase, respectively) in the fellow eye after 16 weeks of treatment. Due to premature study discontinuation, purely descriptive analyses were performed for the primary endpoint. |
| Primary | Plan B - Percentage of Participants Achieving Response in Reduction of Proptosis | Baseline, Week 16 | The percentage of participants achieving response in reduction of proptosis at Week 16 was defined as follows: reduction of \>= 2 mm from Baseline in the study eye without deterioration (\>= 2 mm increase) of proptosis in the fellow eye. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the primary endpoint. |
| Secondary | Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS) | Baseline, Week 16 | The percentage of participants achieving response in reduction of clinical activity score (CAS) at Week 16 was defined as follows: reduction of \>= 2 points from Baseline in the study eye without deterioration (\>= 2 points increase) of CAS in the fellow eye. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis | Baseline, Week 16 | The percentage of participants achieving response in reduction of proptosis at Week 16 was defined as follows: reduction of \>= 2 mm from Baseline in the study eye without deterioration (\>= 2 mm increase) of proptosis in the fellow eye. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Percentage of Participants Achieving Response in Diplopia | Baseline, Week 16 | The percentage of participants achieving response in diplopia at Week 16 was defined as follows: Baseline diplopia \> 0 and a reduction of \>= 1 grade with no corresponding deterioration (\>= 1 grade worsening) in the fellow eye at Week 16. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | Thyroid Eye Disease (TED) activity was assessed using the CAS at the frequency indicated in the study schedule based on the following signs and symptoms in accordance with the European Group on Graves' Orbitopathy (EUGOGO) guideline: * Symptoms * Spontaneous retrobulbar pain * Pain on attempted upward or downward gaze * Signs * Redness of eyelids * Redness of conjunctiva * Swelling of caruncle or plica * Swelling of eyelids * Swelling of conjunctiva (chemosis) For each item present, 1 point is given. The sum of these points is the CAS score, i.e., minimum score of 0 and maximum score of 7. * Inactive TED: CAS \< 3. * Active TED: CAS \>= 3. |
| Secondary | Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | Proptosis measurements were performed at the frequency indicated in the study schedule. The same Hertel instrument, and the same outer intercanthal distance, were to be used for each measurement. The mean of measurements (change from baseline in millimeters (mm) of proptosis, calculated as: (Post-Baseline value - Baseline value) / Baseline value \* 100)) for each group were presented. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | Thyroid Eye Disease (TED) activity was assessed using the CAS at the frequency indicated in the study schedule based on the following signs and symptoms in accordance with the European Group on Graves' Orbitopathy (EUGOGO) guideline. Improvement in EUGOGO disease severity was categorized: Mild, Moderate to severe and Sight threatening. |
| Secondary | Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint. |
| Secondary | Plan A - Number of Participants With Adverse Events | From first dose of study treatment until Week 16 | The distribution of adverse events during Plan A study treatment period was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters. |
| Secondary | Plan B - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS) | Baseline, Week 16 | The percentage of participants achieving response in reduction of CAS at Week 16 was defined as follows: reduction of \>= 2 points from Baseline in the study eye without deterioration (\>= 2 points increase) of CAS in the fellow eye. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Percentage of Participants Achieving Overall Response | Baseline, Week 16 | The percentage of participants achieving overall response was defined as follows: \>= 2 points reduction in CAS AND \>= 2 mm reduction in proptosis from Baseline in the study eye, provided there was no corresponding deterioration in CAS or proptosis (\>= 2 point or 2 mm increase, respectively) in the fellow eye after 16 weeks of treatment. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Percentage of Participants Achieving Response in Diplopia | Baseline, Week 16 | The percentage of participants achieving response in diplopia at Week 16 was defined as follows: Baseline diplopia \> 0 and a reduction of \>= 1 grade with no corresponding deterioration (\>= 1 grade worsening) in the fellow eye at Week 16. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye. | Baseline, Week 16 | Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Mean Change From Baseline to Week 16 in Proptosis in the Study Eye. | Baseline, Week 16 | Proptosis is the protrusion of the eyeball. Exophthalmos means the same, and this term is usually used when describing proptosis due to Grave's disease. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Mean Change From Baseline to Week 16 in the Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Mean Change From Baseline to Week 16 in the Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
| Secondary | Plan B - Number of Participants With Adverse Events | From first dose of study treatment until Week 16 | Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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