Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease

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

Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease (NCT05461820) is a Phase 4 interventional studying Graves Disease and Relapse, sponsored by The First Affiliated Hospital with Nanjing Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Graves Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Methimazole

Methimazole used in this study was produced by Merck, Germany, and its trade name is Thyrozol. The specification of this drug is 10mg/ tablet, and its validity period is 36 months. It was approved by FDA in 2009 and listed in China in 2011.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05461820), the sponsor (The First Affiliated Hospital with Nanjing Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05461820 clinical trial studying?

Who can participate in NCT05461820?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05461820?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT05461820. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05461820. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.