Actively Recruiting
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
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-12-11
240
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of conventional therapy versus intensive therapy on the regulation and recurrence of Graves' disease after stopping medication. This phase IV clinical trial, conducted by the First Affiliated Hospital of Nanjing Medical University, aims to understand how different methimazole dosing strategies affect the cumulative recurrence of Graves' hyperthyroidism two years after drug withdrawal. The study also examines changes in immune markers and inflammatory factors during treatment. Participants receive methimazole with doses adjusted based on thyroid function. In the conventional group, doses are lowered according to thyroid hormone levels over about 24 months. The intensive group uses a fixed middle dose of methimazole plus levothyroxine when hypothyroidism occurs, continuing treatment until thyroid antibodies become negative, followed by gradual dose reductions. Thyroid function and antibodies are monitored every four weeks during treatment. During the study, participants undergo regular thyroid function tests and antibody measurements to assess treatment effects. Researchers track the cumulative recurrence rate of hyperthyroidism up to two years after stopping drugs, as well as adverse reactions during treatment. Secondary outcomes include changes in thyroid volume, thyroid autoantibody levels, and cytokines. The total participation includes the treatment period and up to two years of follow-up after drug withdrawal to evaluate long-term outcomes.
CONDITIONS
Brief Title
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Graves hyperthyroidism
- Age between 18 and 65 years, men and women
- Positive thyroid receptor antibody (TRAb) test
- Voluntary participation with signed informed consent
You will not qualify if you...
- Long-term use of glucocorticoids or other immunosuppressants within 3 months before enrollment
- Participation in other drug trials within 3 months before enrollment
- Current participation in clinical research of other drugs
- History of malignant tumors
- Poorly controlled hypertension (diastolic \u2265 100 mmHg or systolic \u2265 160 mmHg)
- Low white blood cell or neutrophil counts (white blood cells < 3.0 x 10^9/L or neutrophils < 1.5 x 10^9/L)
- Other thyroid diseases such as subacute thyroiditis, thyroid nodules, or high-functioning adenoma
- Elevated liver enzymes above twice the normal limit or positive hepatitis B test
- Renal insufficiency with elevated serum creatinine
- Heart failure or coronary heart disease
- Other autoimmune diseases
- Known allergy to methimazole or its components
- Multiple drug allergies, allergic diseases, high sensitivity, or drug addiction
- Alcoholism, mental disorders, or unsuitable for drug testing
- Pregnant or lactating women who cannot exclude pregnancy
- Use of medicines with unknown ingredients or traditional Chinese medicine affecting hyperthyroidism treatment
- Medical history or circumstances that may affect study participation or follow-up
- Poor compliance with trial protocol or use of other drugs affecting study results
- Allergic or intolerant reactions to the study drug
- Serious adverse events or pregnancy during the trial
- Diseases interfering with study assessments
- Investigator judgment deeming continuation inappropriate
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 months
Participants receive either conventional or intensive methimazole treatment to regulate Graves' disease. Dose adjustments and antibody monitoring occur regularly during treatment to reduce thyroid autoantibodies and manage thyroid function.
Monthly visits for thyroid function and antibody testing
Duration - Up to 2 years after drug withdrawal
Participants are monitored for recurrence of Graves' disease and changes in immune and inflammatory markers after drug withdrawal.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
X
Xuqin Zheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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