Trial · NCT03461211
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
NCT03461211, Phase 3, Completed, Amgen; results first posted 2021-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study. Trials, record NCT03461211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03461211
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
- NCT number
- NCT03461211
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 51 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Thyroid Eye Disease
- Interventions
- Teprotumumab
- First posted
- 2018-03-09
- Last updated
- 2024-06-28
- Other registries' IDs
- eudract:2017-002713-58
- Results first posted
- 2021-07-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24 | Baseline, Week 24 | Proptosis responders were defined as participants with a ≥ 2 mm reduction from study baseline in proptosis in the study eye, without deterioration (≥ 2 mm increase) of proptosis in the fellow eye at Week 24. Participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic. |
| Secondary | Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24 | Week 24 | CAS responders were defined as participants with a reduction to a CAS of 0 or 1 (no or minimal inflammatory symptoms) as a categorical response variable at Week 24. The 7-item CAS assigns 1 point for each of the following items present in the study eye: spontaneous orbital pain; gaze evoked orbital pain; eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/Graves' ophthalmopathy (TED/GO); eyelid erythema; conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); chemosis; inflammation of caruncle or plica. The sum of these points is the total score (0 to 7), with higher scores indicating worse symptoms. |
| Secondary | Change in Proptosis From Baseline to Week 24 | Study Baseline, Week 24 | Mean change from study baseline to Week 24 in proptosis measurement (mm) in the study eye at Week 24. |
| Secondary | Percentage of Participants Who Were Diplopia Responders at Week 24 | Week 24 | Diplopia responders were defined as participants with 1 grade or greater reduction in diplopia score in the study eye without worsening by at least 1 grade in the fellow eye at Week 24. The subjective diplopia score (0=no diplopia; 1=intermittent, i.e. diplopia in primary position of gaze, when tired or when first awakening; 2=inconstant, i.e. diplopia at extremes of gaze; 3=constant, i.e. continuous diplopia in primary or reading position) was recorded for each eye. A participant was considered to have diplopia if a score \> 0 is observed in the study eye at study baseline. |
| Secondary | Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score | Study Baseline, Week 24 | The GO-QoL is a 16-item self-administered questionnaire divided into 2 subsets and used to assess the perceived effects of TED by the participants on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The sum of the scores from each set of 8 questions was calculated and transformed to a scale from 0 (worst) to 100 (best) - one for visual function (VF), one for appearance (A) and one for the overall combined (VF + A) score. Scores were transformed as follows: Transformed score = \[(sum of each score - number of completed items) / (2 \* number of completed items)\] \* 100. The "overall combined (VF + A) score" is also 0 to 100, with higher scores indicating a better outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24 | Baseline, Week 24 | Intent-to-Treat Population: all participants enrolled in the study. Participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic. One participant in the Teprotumumab (OPTIC Teprotumumab) arm was excluded from all Week 24 summaries due to COVID-19 (visit delayed). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24 | Week 24 | Intent-to-Treat Population: all participants enrolled in the study. Participants with CAS \> 1 at Study Baseline. Per the statistical analysis plan, participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic. One participant in the Teprotumumab (OPTIC Teprotumumab) arm was excluded from all Week 24 summaries due to COVID-19 (visit delayed). | percentage of participants | NUMBER |
| SECONDARY | Change in Proptosis From Baseline to Week 24 | Study Baseline, Week 24 | Intent-to-Treat Population: all participants enrolled in the study. Participants with both baseline and Week 24 measurements. One participant in the Teprotumumab (OPTIC Teprotumumab) arm was excluded from all Week 24 summaries due to COVID-19 (visit delayed). | mm | MEAN |
| SECONDARY | Percentage of Participants Who Were Diplopia Responders at Week 24 | Week 24 | Intent-to-Treat Population: all participants enrolled in the study. Participants with diplopia at Study Baseline. Per the statistical analysis plan, participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic. One participant in the Teprotumumab (OPTIC Teprotumumab) arm was excluded from all Week 24 summaries due to COVID-19 (visit delayed). | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score | Study Baseline, Week 24 | Intent-to-Treat Population: all participants enrolled in the study. Participants with both baseline and Week 24 measurements. One participant in the Teprotumumab (OPTIC Teprotumumab) arm was excluded from all Week 24 summaries due to COVID-19 (visit delayed). | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24 | Teprotumumab (OPTIC Placebo) | 89.2 | percentage of participants | ||
| Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24 | Teprotumumab (OPTIC Teprotumumab) | 53.8 | percentage of participants | ||
| Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24 | Teprotumumab (OPTIC Placebo) | 65.6 | percentage of participants | ||
| Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24 | Teprotumumab (OPTIC Teprotumumab) | 36.4 | percentage of participants | ||
| Change in Proptosis From Baseline to Week 24 | Teprotumumab (OPTIC Placebo) | -3.47 | Standard Deviation 1.732 | mm | |
| Change in Proptosis From Baseline to Week 24 | Teprotumumab (OPTIC Teprotumumab) | -1.77 | Standard Deviation 1.126 | mm | |
| Percentage of Participants Who Were Diplopia Responders at Week 24 | Teprotumumab (OPTIC Placebo) | 60.9 | percentage of participants | ||
| Percentage of Participants Who Were Diplopia Responders at Week 24 | Teprotumumab (OPTIC Teprotumumab) | 75.0 | percentage of participants | ||
| Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score | Teprotumumab (OPTIC Placebo) | 13.39 | Standard Deviation 17.890 | score on a scale | |
| Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score | Teprotumumab (OPTIC Teprotumumab) | 14.73 | Standard Deviation 11.777 | score on a scale |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teprotumumab (OPTIC Placebo) | 37 | |
| Overall Study | STARTED | Teprotumumab (OPTIC Teprotumumab) | 14 | |
| Overall Study | Proptosis Non-Responders in OPTIC | Teprotumumab (OPTIC Placebo) | 36 | |
| Overall Study | Proptosis Non-Responders in OPTIC | Teprotumumab (OPTIC Teprotumumab) | 5 | |
| Overall Study | Relapsed During Follow-Up Period of OPTIC | Teprotumumab (OPTIC Placebo) | 1 | |
| Overall Study | Relapsed During Follow-Up Period of OPTIC | Teprotumumab (OPTIC Teprotumumab) | 9 | |
| Overall Study | COMPLETED | Teprotumumab (OPTIC Placebo) | 36 | |
| Overall Study | COMPLETED | Teprotumumab (OPTIC Teprotumumab) | 12 | |
| Overall Study | NOT COMPLETED | Teprotumumab (OPTIC Placebo) | 1 | |
| Overall Study | NOT COMPLETED | Teprotumumab (OPTIC Teprotumumab) | 2 |
Source ClinicalTrials.gov
Adverse events500
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Period: Teprotumumab (OPTIC Placebo) | 0 | 37 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 1 | 14 | |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-Up Period: No Treatment (OPTIC Placebo) | 0 | 36 | |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-Up Period: No Treatment (OPTIC Teprotumumab) | 0 | 4 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Period: Teprotumumab (OPTIC Placebo) | 2 | 37 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 0 | 14 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Follow-Up Period: No Treatment (OPTIC Placebo) | 0 | 36 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Follow-Up Period: No Treatment (OPTIC Teprotumumab) | 0 | 4 | |
| other | Palpitations | Cardiac disorders | Treatment Period: Teprotumumab (OPTIC Placebo) | 1 | 37 | |
| other | Palpitations | Cardiac disorders | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 0 | 14 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period: Teprotumumab (OPTIC Placebo) | 0 | 37 |
| Total, all-cause mortality | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 0 | 14 |
| Total, all-cause mortality | Follow-Up Period: No Treatment (OPTIC Placebo) | 0 | 36 |
| Total, all-cause mortality | Follow-Up Period: No Treatment (OPTIC Teprotumumab) | 0 | 4 |
| Total, other adverse events | Treatment Period: Teprotumumab (OPTIC Placebo) | 32 | 37 |
| Total, other adverse events | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 11 | 14 |
| Total, other adverse events | Follow-Up Period: No Treatment (OPTIC Placebo) | 16 | 36 |
| Total, other adverse events | Follow-Up Period: No Treatment (OPTIC Teprotumumab) | 2 | 4 |
| Total, serious adverse events | Treatment Period: Teprotumumab (OPTIC Placebo) | 0 | 37 |
| Total, serious adverse events | Treatment Period: Teprotumumab (OPTIC Teprotumumab) | 1 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33768488 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03461211
GET https://conductscience.org/api/trials/v1/NCT03461211/events?page=2