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

NCT03066076 | Unknown Phase 3 DMC FDA Drug

• 2 other identifiers: 1839/20152015-003515-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Disease; Graves Ophthalmopathy; Graves' Ophthalmopathy Worsened

Outcome Measures

Primary Outcomes (2)

• Muscle index (MI) from ultrasound measurements

  Muscle index (MI) from ultrasound measurements

  12 months

• Thyroid antibodies

  Thyroid antibodies

  12 months

Secondary Outcomes (3)

• CAScore/NOSPECS score

  12 months

• Superonasal index measurements via ultrasound

  12 months

• Quality of life score

  12 months

Study Arms (2)

Thyroidectomy

ACTIVE COMPARATOR

Total thyroidectomy

Drug: Antithyroid Drug

Antithyroid drug

ACTIVE COMPARATOR

Thiamazol, Propylthiouracil

Procedure: Total thyroidectomy

Interventions

Antithyroid Drug DRUG

Antithyroid drug

Also known as: Thiamazol, Propylthiouracil

Thyroidectomy

Total thyroidectomy PROCEDURE

Operation

Antithyroid drug

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• GD and GO onset \> 12 months
• more than one relapse of GO longer than 6 months from diagnosis
• previous GD treatment by RAI or surgery
• SNI greater than 7.0
• urgent orbital decompression surgery
• loss of vision
• loss of visual field
• loss of color vision
• patients not receiving glucocorticoids for GO
• cytological findings of postsurgical histopathological results suspicious for malignancy
• pregnancy or breast-feeding
• contraindication to GC
• halt of GC therapy
• Patients with diabetes mellitus
• age below 18 years

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Surgery and Department of Ophthalmology Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Graves Disease; Graves Ophthalmopathy

Interventions

Antithyroid Agents; Methimazole; Propylthiouracil

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiouracil; Uracil; Pyrimidinones; Pyrimidines

Study Officials

• Philipp Riss, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Guido Dorner, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Brammen, MD

CONTACT

+4314040056210; lindsay.brammen@meduniwien.ac.at

Philipp Riss, MD

CONTACT

+4314040056210; philipp.riss@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Observer blinded analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 28, 2017
• Study Start: March 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)