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Teprotumumab Treatment in Patients With Active Thyroid Eye Disease

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
River Vision Development Corporation Identifier:
First received: May 2, 2013
Last updated: March 20, 2017
Last verified: March 2017

The purpose of this study is to evaluate the safety, tolerability and effectiveness of a fully human antibody compared to placebo in the treatment of patients with active thyroid eye disease.

"Funding Source - FDA OOPD"

Condition Intervention Phase
Thyroid Associated Ophthalmopathies Thyroid-Associated Ophthalmopathy Drug: teprotumumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients With Active Thyroid Eye Disease

Resource links provided by NLM:

Further study details as provided by River Vision Development Corporation:

Primary Outcome Measures:
  • Responder Analysis - Patients are considered responders if their Week 24 Clinical Activity Score decreases ≥ 2 points AND Proptosis decreases of ≥ 2 mm. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • GO-Quality of Life [ Time Frame: 6 months ]
  • Proptosis as a continuous variable [ Time Frame: 6 months ]
  • Clinical Activity Score as a continuous variable [ Time Frame: 6 months ]

Estimated Enrollment: 84
Study Start Date: July 2013
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline or teprotumumab
Administered as an infusion every 3 weeks for 8 total over 6 months.
Drug: Placebo
Normal saline solution
Other Name: Saline
Experimental: teprotumumab or saline
10mg/kg first infusion then 20mg/kg for remaining 7 infusions administered every 3 weeks over 6 months
Drug: teprotumumab
10mg/kg first infusion then 20mg/kg for remaining 7 infusions administered every 3 weeks over 6 months
Other Name: RV 001

Detailed Description:
A multicenter, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks (q3W) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (TED)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Graves'disease associated with active thyroid eye disease and a clinical activity score of >4
  • Fewer than 9 months from onset of thyroid eye disease
  • No previous medical or surgical treatment, excluding local supportive measures and steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of steroids and randomization
  • Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits. Every effort should be made to correct the mild hypo or hyperthyroidism promptly.

Exclusion Criteria:

  • Optic neuropathy
  • Corneal decompensation unresponsive to medical management
  • Oral or IV steroid treatment for any reason in the preceding 3 months
  • Poorly controlled diabetes
  • Platelets <100 x 109/L
  • Hemoglobin concentration > 2gr/dl below the lower limit of normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01868997

United States, California
Jules Stein Eye Institute at UCLA
Los Angeles, California, United States, 90095
United States, Colorado
University of Denver
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University Department of Ophthalmology
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospitals and Clinics, Department of Ophthalmology
Iowa City, Iowa, United States, 52242
United States, Michigan
Kellogg Eye Center at University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Washington University Department of Ophthalmology
St Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center Department of Ophthalmology
Omaha, Nebraska, United States, 68198
United States, Oregon
Casey Eye Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Hamilton Eye Institute at University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Eye Wellness Center
Houston, Texas, United States, 77005
United States, Wisconsin
Medical College of Wisconsin, The Eye Institute
Milwaukee, Wisconsin, United States, 53226
Johannes Gutenberg University Medical Center
Mainz, Germany, 55101
Fondazione Ca' Granda Ospedale Policlinico Graves GO Center
Milan, Italy, 20122
University of Pisa, Azienda Ospedaliera
Pisa, Italy, 56100
United Kingdom
Moorfields Eye Hospital
London, United Kingdom
Sponsors and Collaborators
River Vision Development Corporation
Principal Investigator: Raymond S Douglas, MD,PhD University of Michigan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: River Vision Development Corporation Identifier: NCT01868997     History of Changes
Other Study ID Numbers: TED01RV
FD004792-01A1 ( Other Identifier: FDA - Office of Orphan Product Development )
Study First Received: May 2, 2013
Last Updated: March 20, 2017

Keywords provided by River Vision Development Corporation:
Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated

Additional relevant MeSH terms:
Thyroid Diseases
Eye Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Autoimmune Diseases
Immune System Diseases
Hyperthyroidism processed this record on August 21, 2017