What side effects are associated with this type of intervention?

Corticosteroids, used for their anti-inflammatory action in treating Graves' Disease, can cause side effects such as hyperglycemia, increased susceptibility to infections, bone loss and fractures, and neuropsychiatric effects like mood swings and insomnia. These side effects are important to consider when using corticosteroids to manage the inflammation and immune response associated with Graves' Disease.

What prior FDA approvals exist?

For the treatment of Graves' Disease, the FDA has approved thionamides such as methimazole and propylthiouracil (PTU) as primary therapies. Radioiodine and surgery are also established definitive treatments. Additionally, corticosteroids are used preoperatively to reduce thyroid gland inflammation, making surgery less difficult.

What other types of research exist?

For Graves' disease patients considering treatment in 2024, promising novel alternatives to corticosteroids include radioiodine therapy and surgery. These options are particularly suitable for patients with large goiters, those allergic to thionamides, or those planning pregnancy. Additionally, biologics such as rituximab and mycophenolate mofetil have shown potential in treating related thyroid conditions and may offer alternative anti-inflammatory benefits.

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Corticosteroid

Dexamethasone for Autoimmune Thyroid Disease

Phase 4

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

Be older than 18 years old

Must not have

Known diagnosis of thyroid cancer

Diabetic patients on medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

All Individual Drugs Already Approved

Approved for 60 Other Conditions

Summary

This trial is testing whether giving patients anti-inflammatory medication (corticosteroids) before thyroid surgery can reduce gland inflammation and make the surgery easier. The focus is on patients with autoimmune thyroid disease, where the immune system attacks the thyroid, causing inflammation.

Who is the study for?

This trial is for adults with Graves' disease or Hashimoto's thyroiditis planning to have their thyroid removed. They must have certain autoantibodies present and not be on immunosuppressants, diabetic medication, or have a history of neck surgeries, steroid therapy, adverse reactions to corticosteroids, or any drug interactions.

What is being tested?

The study is testing if taking a short course of Dexamethasone (a corticosteroid) before surgery can reduce inflammation in the thyroid gland compared to a placebo. Patients are randomly assigned to either receive Dexamethasone or an inactive substance.

What are the potential side effects?

Dexamethasone may cause increased blood sugar levels, mood swings, high blood pressure, weight gain, insomnia and increase the risk of infections. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Graves' or Hashimoto's disease and am having my thyroid removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with thyroid cancer.

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I am diabetic and taking medication for it.

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I have had surgery on my neck before.

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I am on medication that weakens my immune system, including recent steroid use.

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I am under 18 years old.

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I have previously undergone radioactive iodine treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Thyroid difficulty Scale score

Secondary study objectives

Calcium

FT4

Number of participants with the following surgical complications

+11 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SteroidsExperimental Treatment1 Intervention

Will be given pre-operative corticosteroid regimen

Group II: placeboPlacebo Group1 Intervention

Will be given Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Graves' Disease is commonly treated with thionamides (e.g., methimazole), radioactive iodine, and sometimes surgery. Thionamides inhibit thyroid hormone synthesis, while radioactive iodine destroys overactive thyroid tissue. Corticosteroids, such as prednisone, are used for their anti-inflammatory properties; they inhibit peripheral conversion of T4 to T3 and reduce thyroid hormone secretion. This is particularly important for patients experiencing severe hyperthyroidism or thyroid storm, as corticosteroids can rapidly reduce inflammation and hormone levels, providing symptomatic relief and preventing complications.

Focus on Autoimmune Myocarditis in Graves' Disease: A Case-Based Review.Case Report: Novel Dietary Supplementation Associated With Kidney Recovery and Reduction in Proteinuria in a Dialysis Dependent Patient Secondary to Steroid Resistant Minimal Change Disease.Acute management of autoimmune toxicity in cancer patients on immunotherapy: Common toxicities and the approach for the emergency physician.