Trial · NCT03298867
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
NCT03298867, Phase 3, Completed, Amgen; results first posted 2020-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study. Trials, record NCT03298867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03298867
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
- NCT number
- NCT03298867
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Thyroid Eye Disease, Graves' Orbitopathy
- Interventions
- Teprotumumab, Placebo
- First posted
- 2017-10-02
- Last updated
- 2024-07-11
- Other registries' IDs
- eudract:2017-002763-18
- Results first posted
- 2020-03-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Were Proptosis Responders at Week 24 | Week 24 | Proptosis responders were defined as participants with a ≥2 mm reduction from Baseline in proptosis in the study eye, without deterioration (≥2 mm increase) of proptosis in the fellow eye at Week 24. |
| Secondary | Percentage of Participants Who Were Overall Responders at Week 24 | Week 24 | Overall responders were defined as participants with a ≥2 mm reduction in proptosis AND a ≥2 point reduction in Clinical Activity Score (CAS) from Baseline in the study eye, without deterioration (≥2 mm increase in proptosis or ≥2 point increase in CAS) in the fellow eye at Week 24. The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); 6. Chemosis; 7. Inflammation of caruncle or plica. Each item is scored (1=present; 0=absent) and scores for each item are summed for total score of 0 (no clinical activity) to 7 (most clinical activity). |
| Secondary | Percentage of Participants Who Were CAS Categorical Responders at Week 24 (Study Eye) | Week 24 | CAS categorical responders were defined as participants with a reduction to a CAS of 0 or 1 (no or minimal inflammatory symptoms) in study eye. The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); 6. Chemosis; 7. Inflammation of caruncle or plica. Each item is scored (1=present; 0=absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). |
| Secondary | Change From Baseline in Proptosis to Week 24 (Study Eye) | Baseline, up to Week 24 | |
| Secondary | Percentage of Participants Who Were Diplopia Responders at Week 24 | Week 24 | Diplopia responders were defined as participants with Baseline diplopia Subjective Diplopia Score grade \>0 in the study eye who had a reduction of ≥1 grade with no corresponding deterioration (≥1 grade worsening) in the fellow eye at Week 24. Denominator is the number of subjects with diplopia at Baseline. The Subjective Diplopia Score is a clinical measure of diplopia severity on a grade scale of 0 to 3: 0=no diplopia; 1=intermittent (diplopia in primary position of gaze, when tired or when first awakening); 2=inconstant (diplopia at extremes of gaze); 3=constant (continuous diplopia in primary or reading position). |
| Secondary | Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24 | Baseline, up to 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 subjects on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The range of the GO-QoL overall transformed scores is 0 to 100, where higher values correspond to better quality of life. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Were Proptosis Responders at Week 24 | Week 24 | Intent-to-treat population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Overall Responders at Week 24 | Week 24 | Intent-to-treat population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were CAS Categorical Responders at Week 24 (Study Eye) | Week 24 | Intent-to-treat population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Proptosis to Week 24 (Study Eye) | Baseline, up to Week 24 | Intent-to-treat population: all randomized participants. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Were Diplopia Responders at Week 24 | Week 24 | Intent-to-treat population: all randomized participants with diplopia at baseline in the study eye. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24 | Baseline, up to Week 24 | Intent-to-treat population: all randomized participants. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Proptosis Responders at Week 24 | Placebo | 9.5 | percentage of participants | ||
| Percentage of Participants Who Were Proptosis Responders at Week 24 | Teprotumumab 20 mg/kg | 82.9 | percentage of participants | ||
| Percentage of Participants Who Were Overall Responders at Week 24 | Placebo | 7.1 | percentage of participants | ||
| Percentage of Participants Who Were Overall Responders at Week 24 | Teprotumumab 20 mg/kg | 78.0 | percentage of participants | ||
| Percentage of Participants Who Were CAS Categorical Responders at Week 24 (Study Eye) | Placebo | 21.4 | percentage of participants | ||
| Percentage of Participants Who Were CAS Categorical Responders at Week 24 (Study Eye) | Teprotumumab 20 mg/kg | 58.5 | percentage of participants | ||
| Change From Baseline in Proptosis to Week 24 (Study Eye) | Placebo | -0.54 | Standard Error 0.192 | mm | |
| Change From Baseline in Proptosis to Week 24 (Study Eye) | Teprotumumab 20 mg/kg | -2.82 | Standard Error 0.191 | mm | |
| Percentage of Participants Who Were Diplopia Responders at Week 24 | Placebo | 28.6 | percentage of participants | ||
| Percentage of Participants Who Were Diplopia Responders at Week 24 | Teprotumumab 20 mg/kg | 67.9 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Masked 24-Week Treatment Period | STARTED | Placebo | 42 | |
| Double-Masked 24-Week Treatment Period | STARTED | Teprotumumab 20 mg/kg | 41 | |
| Double-Masked 24-Week Treatment Period | COMPLETED | Placebo | 40 | |
| Double-Masked 24-Week Treatment Period | COMPLETED | Teprotumumab 20 mg/kg | 39 | |
| Double-Masked 24-Week Treatment Period | NOT COMPLETED | Placebo | 2 | |
| Double-Masked 24-Week Treatment Period | NOT COMPLETED | Teprotumumab 20 mg/kg | 2 | |
| 48-Week Follow-Up Period (Weeks 24-72) | STARTED | Placebo | 4 | |
| 48-Week Follow-Up Period (Weeks 24-72) | STARTED | Teprotumumab 20 mg/kg | 36 | |
| 48-Week Follow-Up Period (Weeks 24-72) | COMPLETED | Placebo | 3 | |
| 48-Week Follow-Up Period (Weeks 24-72) | COMPLETED | Teprotumumab 20 mg/kg | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
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 | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 3 | 42 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Teprotumumab 20 mg/kg | 2 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 42 | |
| other | Diarrhoea | Gastrointestinal disorders | Teprotumumab 20 mg/kg | 5 | 41 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 42 | |
| other | Nausea | Gastrointestinal disorders | Teprotumumab 20 mg/kg | 6 | 41 | |
| other | Stomatitis | Gastrointestinal disorders | Placebo | 1 | 42 | |
| other | Stomatitis | Gastrointestinal disorders | Teprotumumab 20 mg/kg | 3 | 41 | |
| other | Fatigue | General disorders | Placebo | 1 | 42 | |
| other | Fatigue | General disorders | Teprotumumab 20 mg/kg | 5 | 41 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, all-cause mortality | Teprotumumab 20 mg/kg | 0 | 41 |
| Total, other adverse events | Placebo | 29 | 42 |
| Total, other adverse events | Teprotumumab 20 mg/kg | 37 | 41 |
| Total, serious adverse events | Placebo | 1 | 42 |
| Total, serious adverse events | Teprotumumab 20 mg/kg | 2 | 41 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Teprotumumab 20 mg/kg vs Placebo: deaths from any cause | Trial comparisons |
| Teprotumumab 20 mg/kg vs Placebo: serious adverse events | Trial comparisons |
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/NCT03298867
GET https://conductscience.org/api/trials/v1/NCT03298867/events?page=2