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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01868997
Other study ID # TED01RV
Secondary ID FD004792-01A1201
Status Completed
Phase Phase 2
First received May 2, 2013
Last updated March 27, 2018
Start date July 2013
Est. completion date February 22, 2017

Study information

Verified date March 2018
Source Horizon Pharma USA, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.

"Funding Source - FDA OOPD"


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date February 22, 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Graves' disease associated with active TED and a clinical activity score of = 4

- Fewer than 9 months from onset of TED

- No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral 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 non-TED reason in the preceding 3 months

- Poorly controlled diabetes

- Platelets < 100 x 10^9/L

- Hemoglobin concentration > 2 g/dL below the lower limit of normal

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
teprotumumab

normal saline


Locations

Country Name City State
Germany Johannes Gutenberg University Medical Center Mainz
Italy Fondazione Ca' Granda Ospedale Policlinico Graves GO Center Milan
Italy University of Pisa, Azienda Ospedaliera Pisa
United Kingdom Moorfields Eye Hospital London
United States Kellogg Eye Center at University of Michigan Ann Arbor Michigan
United States Emory University Department of Ophthalmology Atlanta Georgia
United States University of Denver Aurora Colorado
United States Eye Wellness Center Houston Texas
United States University of Iowa Hospitals and Clinics, Department of Ophthalmology Iowa City Iowa
United States Jules Stein Eye Institute at UCLA Los Angeles California
United States Hamilton Eye Institute at University of Tennessee Memphis Tennessee
United States Medical College of Wisconsin, The Eye Institute Milwaukee Wisconsin
United States University of Nebraska Medical Center Department of Ophthalmology Omaha Nebraska
United States Casey Eye Institute at Oregon Health and Science University Portland Oregon
United States Washington University Department of Ophthalmology Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Horizon Pharma USA, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Italy,  United Kingdom, 

References & Publications (1)

Smith TJ, Kahaly GJ, Ezra DG, Fleming JC, Dailey RA, Tang RA, Harris GJ, Antonelli A, Salvi M, Goldberg RA, Gigantelli JW, Couch SM, Shriver EM, Hayek BR, Hink EM, Woodward RM, Gabriel K, Magni G, Douglas RS. Teprotumumab for Thyroid-Associated Ophthalmop — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Responder Status at 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. Week 24
Secondary Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM]) 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). Baseline to Week 24
Secondary Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM) 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. Baseline to Week 24
Secondary Overall Average Change From Baseline in CAS to Week 24 (MMRM) 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. Baseline to Week 24
Secondary Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM) 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. Baseline to Week 24
Secondary Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM) 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. Baseline to Week 24
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