The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Study Overview
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Brief Summary
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Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation of thyroid gland and destroys thyroid tissue. Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis(RA) for more than one century. The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment of Hashimoto's thyroiditis.

Detailed Description
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Hashimoto's thyroiditis is an autoimmune thyroid disease, and when the disease progresses, thyroid function finally declined to hypothyroidism. There was no medical treatment recommended for patients with Hashimoto's thyroiditis, but currently at euthyroid state. Levothyroxine replacement therapy starts if patients become hypothyroid state. Hashimoto's thyroiditis is a T-cell mediated autoimmune thyroid disease. The major auto-antigens include thyroid peroxidase (TPO) and thyroglobulin. Anti-TPO antibodies induce antibody-dependent cell-mediated cytotoxicity (ADCC) and cause destruction of thyroid tissues. Antimalarial agents like hydroxychloroquine have several pharmacologic effects which may be involved in the treatment of rheumatic diseases, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, nicotinamide adenine dinucleotide hydrogen-cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosome membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis. This study is to investigate the treatment effect of hydroxychloroquine on autoantibodies and disease progression of Hashimoto's thyroiditis.

Official Title
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The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Conditions
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Hashimoto Thyroiditis

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hashimoto's thyroiditis Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit) Never receive immunomodulators or immunosuppressants Exclusion Criteria: Planned pregnant or already pregnant women Renal insufficiency Hepatic insufficiency Anemia Agranulocytosis Thrombocytopenia Glucose-6-phosphate dehydrogenase deficiency Porphyria cutaneous tarda Allergy to 4-aminoquinolone

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>Receive treatment with hydroxychloroquine | Drug: Hydroxychloroquine<br>* Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months<br>* Other names: Plaquenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-TPO antibody | Check anti-TPO antibody 6 months after medical treatment as inflammatory marker | 6th month after medical treatment | 
| Anti-thyroglobulin antibody | Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status | 6 months after medical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity of thyroid gland | Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid | 6 months after medical treatment | 
| Thyroid function | Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment | 6 months after medical treatment | 
| Inflammatory cytokines | Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment | 6 months after treatment |