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Teprotumumab Treatment in Patients With Active Thyroid Eye Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by River Vision Development Corporation
Sponsor:
Information provided by (Responsible Party):
River Vision Development Corporation
ClinicalTrials.gov Identifier:
NCT01868997
First received: May 2, 2013
Last updated: July 29, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Clinical Activity Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Severity Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Administered as an infusion every 3 weeks for 8 total over 6 months.
Drug: Placebo
Experimental: teprotumumab
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01868997

Contacts
Contact: Amber Sarot 619-334-6502 amber.sarot@premier-research.com
Contact: Jeannette Reed 215-282-5459 jeannette.reed@premier-research.com

  Show 20 Study Locations
Sponsors and Collaborators
River Vision Development Corporation
Investigators
Principal Investigator: Raymond S Douglas, MD,PhD University of Michigan
  More Information

No publications provided by River Vision Development Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: River Vision Development Corporation
ClinicalTrials.gov Identifier: NCT01868997     History of Changes
Other Study ID Numbers: TED01RV
Study First Received: May 2, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

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

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
Exophthalmos
Goiter
Hyperthyroidism

ClinicalTrials.gov processed this record on September 18, 2014