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Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy

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ClinicalTrials.gov Identifier: NCT03066076
Recruitment Status : Unknown
Verified February 2017 by Philipp Riss, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Philipp Riss, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE February 28, 2017
Last Update Posted Date February 28, 2017
Estimated Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Muscle index (MI) from ultrasound measurements [ Time Frame: 12 months ]
    Muscle index (MI) from ultrasound measurements
  • Thyroid antibodies [ Time Frame: 12 months ]
    Thyroid antibodies
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • CAScore/NOSPECS score [ Time Frame: 12 months ]
    CAScore/NOSPECS score
  • Superonasal index measurements via ultrasound [ Time Frame: 12 months ]
    Superonasal index measurements via ultrasound
  • Quality of life score [ Time Frame: 12 months ]
    Quality of life score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
Official Title  ICMJE Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) Versus Thionamides (Anti-Thyroid Drugs) in Patients With Moderate-to-Severe Graves' Ophthalmopathy - a 1-year Follow-up
Brief Summary

Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.

Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.

Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.

Detailed Description

Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.

Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.

Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
Observer blinded analysis
Primary Purpose: Treatment
Condition  ICMJE
  • Graves Disease
  • Graves Ophthalmopathy
  • Graves' Ophthalmopathy Worsened
Intervention  ICMJE
  • Drug: Antithyroid Drug
    Antithyroid drug
    Other Names:
    • Thiamazol
    • Propylthiouracil
  • Procedure: Total thyroidectomy
    Operation
Study Arms  ICMJE
  • Active Comparator: Thyroidectomy
    Total thyroidectomy
    Intervention: Drug: Antithyroid Drug
  • Active Comparator: Antithyroid drug
    Thiamazol, Propylthiouracil
    Intervention: Procedure: Total thyroidectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 22, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. GD and GO onset < 12 months
  2. no previous GD treatment other than antithyroid drugs (ATD)
  3. first relapse after decrease of antithyroid medication within 4-6 months
  4. GO treatment with glucocorticoids based on the Kahaly scheme
  5. patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
  6. clinically active inflammation according to CAScore (>3/7)
  7. informed consent

Exclusion Criteria:

  1. GD and GO onset > 12 months
  2. more than one relapse of GO longer than 6 months from diagnosis
  3. previous GD treatment by RAI or surgery
  4. SNI greater than 7.0
  5. urgent orbital decompression surgery
  6. loss of vision
  7. loss of visual field
  8. loss of color vision
  9. patients not receiving glucocorticoids for GO
  10. cytological findings of postsurgical histopathological results suspicious for malignancy
  11. pregnancy or breast-feeding
  12. contraindication to GC
  13. halt of GC therapy
  14. Patients with diabetes mellitus
  15. age below 18 years
  16. no informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03066076
Other Study ID Numbers  ICMJE 1839/2015
2015-003515-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD sharing
Responsible Party Philipp Riss, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philipp Riss, MD Medical University Vienna
Principal Investigator: Guido Dorner, MD Medical University Vienna
PRS Account Medical University of Vienna
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP