Dexamethasone for Autoimmune Thyroid Disease

Recruiting at 5 trial locations

Overseen By Hannah Allison, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Diabetes, Thyroid cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a short course of dexamethasone, a corticosteroid, can reduce inflammation in the thyroid gland for individuals with autoimmune thyroid diseases like Graves' disease or Hashimoto's disease. Reducing inflammation may simplify thyroid removal surgery. Participants will receive either the steroid or a placebo (a harmless pill with no active medicine) before surgery. Ideal candidates are those planning to have their thyroid removed due to Graves' or Hashimoto's disease, confirmed by specific thyroid antibodies (proteins that mistakenly attack the thyroid). As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients on immunosuppressive drugs or those with a recent history of steroid therapy. If you are on these medications, you may not be eligible to participate.

What is the safety track record for Dexamethasone?

Research has shown that dexamethasone is generally safe for individuals with autoimmune thyroid issues. One study found that patients with these thyroid conditions who took medications like dexamethasone did not face a higher risk of complications. Although they experienced slightly lower calcium levels immediately after surgery, this was not harmful.

Additionally, individuals with a history of thyroid problems have responded well to dexamethasone, with no major safety issues reported. This suggests that most people tolerate the treatment well. Overall, dexamethasone is considered safe for treating autoimmune thyroid diseases. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dexamethasone is unique because it utilizes corticosteroids to reduce inflammation quickly, potentially offering faster relief for autoimmune thyroid disease compared to current treatments like antithyroid medications or thyroid hormone replacement. While standard treatments often focus on managing hormone levels, dexamethasone targets the underlying inflammation that can exacerbate symptoms. Researchers are excited about its potential to offer a more immediate and direct approach to reducing thyroid inflammation, which could lead to improved outcomes for patients dealing with the condition.

What is the effectiveness track record for Dexamethasone in treating autoimmune thyroid disease?

Research has shown that dexamethasone, which participants in this trial may receive, can help reduce swelling in autoimmune thyroid diseases. In one study, a 71-year-old woman with an overactive thyroid due to an autoimmune condition improved significantly after taking dexamethasone. Another study found that injecting dexamethasone directly into the thyroid lowered the chances of the disease returning in patients with Graves' disease after they stopped other treatments. Additionally, research showed that high doses of dexamethasone helped 73.6% of patients fully recover. These findings suggest that dexamethasone can reduce inflammation and might make thyroid surgery easier for people with autoimmune thyroid issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Alexandria McDow, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I have been diagnosed with thyroid cancer.

I have had surgery on my neck before.

I am taking medication that doesn't mix well with corticosteroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive a short course of corticosteroids or placebo before surgery to reduce thyroid inflammation

1-2 weeks

Surgery

Participants undergo surgery for autoimmune, inflammatory thyroid disease

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of surgical complications and thyroid function

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Steroids Experimental Treatment 1 Intervention

Will be given pre-operative corticosteroid regimen

Group II: placebo Placebo Group 1 Intervention

Will be given Placebo

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

A 71-year-old woman with autoimmune hyperthyroidism and ACTH deficiency showed significant improvement in her symptoms and thyroid condition after receiving hydrocortisone replacement therapy, indicating the efficacy of glucocorticoids in managing her autoimmune thyroid disease.

The case suggests that low cortisol levels may contribute to hyperimmunity and autoimmune thyroid disease, as the patient's hyperthyroidism resolved rapidly with glucocorticoid treatment, leading to decreased thyroid antibody levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoimmune hyperthyroidism due to secondary adrenal insufficiency: resolution with glucocorticoids. Skamagas, M., Geer, EB.[2022]

Autoimmune thyroid disease includes conditions like Hashimoto's thyroiditis and Graves' disease, which can lead to serious complications such as hypothyroidism and extrathyroidal manifestations like ophthalmopathy.

In the U.S., most adults with Graves' disease receive radioiodine therapy for treatment, while those with Hashimoto's thyroiditis often require lifelong levothyroxine therapy if they develop hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying autoimmune thyroid disease. Which disorders require treatment? Fatourechi, V.[2016]

In a study involving 4 hyperthyroid patients with Graves' disease, a daily dose of 30 mg prednisolone rapidly normalized serum T4 and T3 levels within 2 weeks, demonstrating its efficacy in managing hyperthyroidism.

Prednisolone was effective as a preoperative preparation for subtotal thyroidectomy, especially for patients who experienced adverse effects from traditional antithyroid drugs, suggesting it can be a valuable alternative treatment in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid improvement of thyroid function by using glucocorticoid indicated for the preoperative preparation of subtotal thyroidectomy in Graves' disease. Ozawa, Y., Daida, H., Shimizu, T., et al.[2019]

Dexamethasone administration led to a significant increase in serum reverse T3 (rT3) levels and a decrease in serum triiodothyronine (T3) levels in both hypothyroid and hyperthyroid patients, indicating a shift in thyroid hormone metabolism.

The study suggests that dexamethasone alters the conversion of thyroxine (T4) to T3 and rT3, potentially reducing T3 production while enhancing rT3 production, and also appears to lower circulating thyroid hormones in hyperthyroid patients by decreasing thyroid secretion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opposite effects of dexamethasone on serum concentrations of 3,3',5'-triiodothyronine (reverse T3) and 3,3'5-triiodothyronine (T3). Chopra, IJ., Williams, DE., Orgiazzi, J., et al.[2013]

In a study involving 22 patients with Hashimoto's thyroiditis, administering 2 mg of dexamethasone for 2-4 weeks led to a decrease in plasma T4, T3, and TSH levels in euthyroid patients, indicating a reduction in thyroid activity and size.

In contrast, in hypothyroid patients with high TSH levels, dexamethasone increased plasma T3 and T4 levels, suggesting that it may stimulate hormone synthesis by reducing autoimmune processes that inhibit thyroid function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An increase of plasma triiodothyronine and thyroxine after administration of dexamethasone to hypothyroid patients with Hashimoto's thyroiditis. Yamada, T., Ikejiri, K., Kotani, M., et al.[2013]

L-thyroxine (T4) treatment in euthyroid pediatric patients with type 1 diabetes and autoimmune thyroiditis stabilizes autoimmune inflammation in the thyroid gland, as evidenced by decreased levels of anti-thyroid peroxidase antibodies over 24 months.

The study involved 101 children receiving L-T4 and 160 under observation, showing that T4 treatment led to significant changes in thyroid hormone levels, including a decrease in TSH and an increase in free T4, suggesting it may help prevent progression to hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-thyroxine stabilizes autoimmune inflammatory process in euthyroid nongoitrous children with Hashimoto's thyroiditis and type 1 diabetes mellitus. Korzeniowska, K., Jarosz-Chobot, P., Szypowska, A., et al.[2022]

A study involving 21 patients with Graves's ophthalmopathy found that pulse dexamethasone therapy is a cost-effective alternative to pulse methylprednisolone therapy, reducing treatment costs by at least 1/8th.

Dexamethasone therapy not only proved to be equally effective but also showed a better reduction in exophthalmos and did not carry the risk of fulminant hepatic failure associated with high-dose methylprednisolone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse dexamethasone therapy versus pulse methylprednisolone therapy for treatment of Graves's ophthalmopathy. Philip, R., Saran, S., Gutch, M., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-4-hashimoto-disease-6-2022-fb02b

Dexamethasone for Autoimmune Thyroid Disease A 71-year-old woman with autoimmune hyperthyroidism and ACTH deficiency showed significant improvement in her symptoms and thyroid condition after receiving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522220/

Intrathyroid injection of dexamethasone inhibits Th2 cells in ... In our previous study, an intrathyroid injection of DEX (IID) could effectively reduce the relapse rate in GD patients after withdrawing MMI treatment ( 17 ).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8044565/

Clinical efficacy of high-dose dexamethasone with ... Fifty-three obtained complete remission (CR) (73.6%), and 39 achieved continuous CR at 6 months (54.2%). Among 36 anti-nuclear antibody-positive patients, 100% ...

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-020-03188-8

Early administration of glucocorticoid for thyroid storm The in-hospital mortality rate was 8.4% (17/203) in the glucocorticoid treatment group and 11.8% (24/203) in the control group. The 30-day ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05435547?tab=results

Preoperative Corticosteroids in Autoimmune Thyroid Disease An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05435547?term=AREA%5BConditionSearch%5D(%22Thyroiditis%22)%20AND%20AREA%5BInterventionSearch%5D(%22Gastrointestinal%20Agents%22)&rank=2

Preoperative Corticosteroids in Autoimmune Thyroid Disease Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/joim.13743

Disease‐modifying antirheumatic drugs and risk of ... We hypothesized that disease-modifying antirheumatic drugs (DMARDs) as used in RA might lower the risk of incident AITD.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480423005917

Outcomes of Preoperative Medical Therapy for ... Patients who received corticosteroids preoperatively had no increased risk of complications. They did have mildly lower calcium levels in the early ...