Trial · NCT01868997
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
NCT01868997, Phase 2, Completed, Amgen; results first posted 2017-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease. Trials, record NCT01868997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01868997
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
- NCT number
- NCT01868997
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 88 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy
- Interventions
- teprotumumab, normal saline
- First posted
- 2013-06-05
- Last updated
- 2024-12-17
- Other registries' IDs
- eudract:2014-000113-31
- Results first posted
- 2017-08-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder Status at Week 24 | Week 24 | Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders. |
| Secondary | Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM]) | Baseline to Week 24 | The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid eye disorder (TED) 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). |
| Secondary | Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM) | Baseline to Week 24 | Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded using the Hertel exophthalmometer. Participants with a decrease ≥ 2 mm were considered improving, those with an increase or decrease \< 2 mm were considered remaining stable, and those with an increase ≥ 2 mm were considered worsening. |
| Secondary | Overall Average Change From Baseline in CAS to Week 24 (MMRM) | Baseline to Week 24 | The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity. |
| Secondary | Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM) | Baseline to Week 24 | The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED 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. Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 100 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered. |
| Secondary | Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM) | Baseline to Week 24 | The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED 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. Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 100 (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. |
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 | Responder Status at Week 24 | Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM]) | Baseline to Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM) | Baseline to Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Average Change From Baseline in CAS to Week 24 (MMRM) | Baseline to Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM) | Baseline to Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM) | Baseline to Week 24 | Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Status at Week 24 | Placebo | Responder | 9 | Participants | |
| Responder Status at Week 24 | Teprotumumab | Responder | 29 | Participants | |
| Responder Status at Week 24 | Placebo | Non-Responder / Missing | 36 | Participants | |
| Responder Status at Week 24 | Teprotumumab | Non-Responder / Missing | 13 | Participants | |
| Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM]) | Placebo | 6.77 | Standard Error 2.251 | units on a scale | |
| Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM]) | Teprotumumab | 17.74 | Standard Error 2.423 | units on a scale | |
| Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM) | Placebo | -0.15 | Standard Error 0.188 | mm | |
| Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM) | Teprotumumab | -2.46 | Standard Error 0.200 | mm | |
| Overall Average Change From Baseline in CAS to Week 24 (MMRM) | Placebo | -1.85 | Standard Error 0.172 | units on a scale | |
| Overall Average Change From Baseline in CAS to Week 24 (MMRM) | Teprotumumab | -3.43 | Standard Error 0.181 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 45 | |
| Overall Study | STARTED | Teprotumumab | 42 | |
| Overall Study | COMPLETED | Placebo | 38 | |
| Overall Study | COMPLETED | Teprotumumab | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Teprotumumab | 6 |
Source ClinicalTrials.gov
Adverse events42
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 | Diarrhoea | Gastrointestinal disorders | Safety Population: Placebo | 2 | 44 | |
| other | Diarrhoea | Gastrointestinal disorders | Safety Population: Teprotumumab | 5 | 43 | |
| other | Nausea | Gastrointestinal disorders | Safety Population: Placebo | 4 | 44 | |
| other | Nausea | Gastrointestinal disorders | Safety Population: Teprotumumab | 8 | 43 | |
| other | Fatigue | General disorders | Safety Population: Placebo | 6 | 44 | |
| other | Fatigue | General disorders | Safety Population: Teprotumumab | 3 | 43 | |
| other | Upper respiratory tract infection | Infections and infestations | Safety Population: Placebo | 4 | 44 | |
| other | Upper respiratory tract infection | Infections and infestations | Safety Population: Teprotumumab | 0 | 43 | |
| other | Weight decreased | Investigations | Safety Population: Placebo | 0 | 44 | |
| other | Weight decreased | Investigations | Safety Population: Teprotumumab | 3 | 43 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population: Placebo | 0 | 44 |
| Total, all-cause mortality | Safety Population: Teprotumumab | 0 | 43 |
| Total, other adverse events | Safety Population: Placebo | 21 | 44 |
| Total, other adverse events | Safety Population: Teprotumumab | 25 | 43 |
| Total, serious adverse events | Safety Population: Placebo | 1 | 44 |
| Total, serious adverse events | Safety Population: Teprotumumab | 5 | 43 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Safety Population: Teprotumumab vs Safety Population: Placebo: deaths from any cause | Trial comparisons |
| Safety Population: Teprotumumab vs Safety Population: 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/NCT01868997
GET https://conductscience.org/api/trials/v1/NCT01868997/events?page=2