Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07040306
Enrollment
1000
Registered
2025-06-27
Start date
2012-11-14
Completion date
2030-12-01
Last updated
2025-07-09

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

Conditions

Graves´ Disease

Brief summary

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.

Interventions

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.

Sponsors

First Hospital of China Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1. Age ≥18 years old. 2. Newly diagnosed GD and GD relapses.

Exclusion criteria

1. Patients with active infiltrative exophthalmos in GD were excluded. 2. Patients with other autoimmune diseases affecting thyroid function were excluded. 3. Excluding patients with combined malignancies and other serious diseases.

Design outcomes

Primary

MeasureTime frameDescription
Relapse and remission of Graves' disease in adult treated with methimazole.30 yearsRelapse 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.
Adverse effects of methimazole in the treatment of Graves' disease in adult.30 yearsAdverse 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

MeasureTime frameDescription
Thyrotropin receptor antibody(TRAb)30 yearsTo investigate the sensitivity and specificity of the thyrotropin receptor antibody(TRAb) in the diagnosis of GD in China and its role in predicting recurrence
The serum alkaline phosphatase30 yearsAfter 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

Countries

China

Contacts

Primary ContactXiaochun Teng, Medical Doctor (MD)
tengxiaochun@126.com+8613704049020

Outcome results

None listed

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