Skip to content

TSI and Its Relationship With Graves' Disease Relapse

Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05713097
Enrollment
352
Registered
2023-02-06
Start date
2022-01-02
Completion date
2022-08-31
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Thyroid Antibodies Disorder, Graves Disease, Immunoglobulin

Keywords

TSI, recurrent Graves' disease, Graves' ophthalmopathy, treatment duration, anti-thyroid drug, cut-off

Brief summary

The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are: 1. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD. 2. To determine an optimal cut-off of TSI level for predicting GD relapse. 3. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.

Detailed description

Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.

Interventions

DIAGNOSTIC_TESTTSI

TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association. * TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.

Exclusion criteria

* Hyperthyroidism due to other causes * Patients who were intolerant to ATD or had serious side effects with ATD. * TSIs were measured in pregnancy. * Patients treated with surgery or radioactive iodine.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with GD relapseat least 1 year after ATD withdrawalPatients who had relapse of hyperthyroidism due to GD

Secondary

MeasureTime frameDescription
TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.before ATD withdrawalTSI level before planning for ATD withdrawal
Optimal cut-off of TSI level for predicting GD relapsebefore ATD withdrawalOptimal cut-off of TSI level before ATD withdrawal for predicting GD relapse

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026