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Trial record 7 of 42 for:    eye diseases AND university of iowa

Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease

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ClinicalTrials.gov Identifier: NCT01868997
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : August 30, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Thyroid Associated Ophthalmopathies
Thyroid-Associated Ophthalmopathy
Interventions: Drug: teprotumumab
Drug: normal saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 88 participants were enrolled (all participants who signed informed consent were considered enrolled in this study); 1 participant was never dosed and early terminated.

Reporting Groups
  Description
Placebo A placebo infusion (normal saline) was administered once every 3 weeks (q3W) by intravenous (IV) infusion over a period of 24 weeks for a total of 8 infusions.
Teprotumumab Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.

Participant Flow:   Overall Study
    Placebo   Teprotumumab
STARTED   45 [1]   42 [1] 
COMPLETED   38   36 
NOT COMPLETED   7   6 
Adverse Event                2                5 
Lack of Efficacy                2                0 
Not Specified                3                1 
[1] randomized and treated



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
Teprotumumab Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
Total Total of all reporting groups

Baseline Measures
   Placebo   Teprotumumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   42   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.1  (12.87)   51.7  (10.78)   52.9  (11.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  80.0%      28  66.7%      64  73.6% 
Male      9  20.0%      14  33.3%      23  26.4% 


  Outcome Measures

1.  Primary:   Responder Status at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Overall Average Change From Baseline in Graves’ Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM])   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:   Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM)   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Overall Average Change From Baseline in CAS to Week 24 (MMRM)   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:   Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM)   [ Time Frame: Baseline to Week 24 ]

6.  Secondary:   Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM)   [ Time Frame: Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Julie Ball, Executive Director
Organization: Horizon Pharma USA, Inc.
e-mail: clinicaltrials@horizonpharma.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Horizon Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT01868997     History of Changes
Other Study ID Numbers: TED01RV
FD004792-01A1 ( Other Identifier: FDA - Office of Orphan Product Development (OOPD) )
2014-000113-31 ( EudraCT Number )
First Submitted: May 2, 2013
First Posted: June 5, 2013
Results First Submitted: August 10, 2017
Results First Posted: August 30, 2017
Last Update Posted: April 25, 2018