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NCT Number: NCT07040306

A Clinical Follow-up Study on Drug Therapy for Graves' Disease Patients in China

This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software; 2. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment; 3. To investigate the sensitivity and specificity of TRAb in the diagnosis of GD in China and its role in predicting recurrence; 4. After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index.

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Key information

Conditions

Graves´ Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

Location contact

Xiaochun Teng, Medical Doctor (MD)

CONTACT

[email protected]

+8613704049020

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old.
  • Newly diagnosed GD and GD relapses.

Exclusion criteria

  • Patients with active infiltrative exophthalmos in GD were excluded.
  • Patients with other autoimmune diseases affecting thyroid function were excluded.
  • Excluding patients with combined malignancies and other serious diseases.

Treatment and study plan

Methimazole(MMI)

Drug

Determine the enrolled GD patients and adjust the dosage of methimazole according to the 2016 American Thyroid Association guidelines. Conduct thyroid function, liver function, TRAb, and blood routine tests during outpatient follow-up to observe the treatment effect and provide medication guidance.

Primary outcomes

  1. Relapse and remission of Graves' disease in adult treated with methimazole.

    Time frame: 30 years

    Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software.

  2. Adverse effects of methimazole in the treatment of Graves' disease in adult.

    Time frame: 30 years

    Adverse effects are defined as having neutropenia (absolute neutrophil count< 1800/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment

Secondary outcomes

  1. Thyrotropin receptor antibody(TRAb)

    Time frame: 30 years

    To investigate the sensitivity and specificity of the thyrotropin receptor antibody(TRAb) in the diagnosis of GD in China and its role in predicting recurrence

  2. The serum alkaline phosphatase

    Time frame: 30 years

    After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochun Teng, Medical Doctor (MD)

CONTACT

[email protected]

+8613704049020

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

A Prospective Clinical Follow-up Study of Drug Treatment in Patients With Graves' Disease

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Jun 27, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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