Evaluating treatment approaches for Graves' disease management

Clinical Study on the Effect of Routine Treatment and Intensive Treatment on the Regulation of Graves' Disease and the Cumulative Recurrence Two Years After Drug Withdrawal

This study is testing different ways to use methimazole to treat Graves' disease and see how well they work in preventing the condition from coming back after stopping the medication for two years.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT05461820 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of different treatment schemes using methimazole on Graves' hyperthyroidism, focusing on how varying doses are adjusted based on thyroid function states. It aims to evaluate the recurrence rates of the condition after a two-year drug withdrawal period, comparing conventional and intensive therapy approaches. Additionally, the study assesses changes in immune indexes and inflammatory factors during the treatment process. Conducted by the First Affiliated Hospital of Nanjing Medical University, this phase IV clinical trial employs a randomized, open-label design with a parallel control group.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with Graves' hyperthyroidism who test positive for thyroid receptor antibodies.

Not a fit: Patients with a history of malignant tumors or those with poorly controlled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for Graves' disease, potentially reducing recurrence rates and enhancing patient outcomes.

How similar studies have performed: While there have been studies on Graves' disease treatment, this specific approach of adjusting methimazole dosage based on multiple autoantibodies is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
* Age 18-65, for both men and women
* Thyroid receptor antibody (TRAb) was positive
* Take part in this research voluntarily and sign the informed consent form

Exclusion Criteria:

* Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected
* Those who have participated in any other drug trials within 3 months before being selected
* Subjects who are participating in clinical research of other drugs
* Patients with a history of malignant tumors
* Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg
* Blood routine: the total number of white blood cells \< 3.0×109 or neutrophils \< 1.5× 109
* Other thyroid diseases: such as subacute thyroiditis, thyroid nodules, high-function adenoma
* Alanine aminotransferase(ALT) or aspartate amino transferase(AST) is greater than 2 times of the normal upper limit; When ALT or AST is less than 2 times of the normal upper limit, and the test of hepatitis B two half-and-half positive
* Renal insufficiency: serum creatinine is higher than the upper limit of normal value
* Patients with heart failure
* Patients with coronary heart disease
* Patients with other autoimmune diseases
* Patients who are known to be allergic to any component of this medicine are allergic to the active ingredients or any auxiliary materials in the prescription
* Patients with multiple drug allergies, allergic diseases, people with high sensitivity and drug addicts
* Alcoholism, mental disorder or other observers who are not suitable for drug testing
* Pregnant and lactating women cannot rule out the possibility of pregnancy
* Taking any medicine with unknown ingredients or using traditional Chinese medicine, the researcher judges the medicine that may affect the curative effect of hyperthyroidism
* According to the researcher's judgment, other medical history that reduces the possibility of joining the group or complicates the joining of the group, such as frequent changes in the working environment, may easily lead to lost follow-up.

Rejection Criteria:

* The compliance of this clinical trial protocol is \< 80% or \> 120%;
* Those who did not meet the inclusion criteria or the exclusion criteria were found during the experiment;
* Those who can't cooperate, including those who can't complete the whole course of treatment, don't complete the follow-up as planned, and increase or decrease adjuvant drugs at will;
* During the trial, use other drugs that may affect the curative effect of this trial.

Termination of Research Criteria:

* Those who are allergic or intolerant to this drug;
* Adverse reactions or serious adverse events that patients can't tolerate occur;
* Pregnant women of childbearing age in the experiment;
* Other diseases appear during the treatment, and the treatment of accompanying diseases will interfere with the clinical observers of this medicine;
* The researcher thinks it is inappropriate to continue the experiment.

Where this trial is running

Nanjing

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Xuqin Zheng

Conditions: Graves Disease, Relapse, Treatment, Drug Withdrawal