The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Hashimoto Thyroiditis Clinical Trial

Official title: The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hashimoto Disease
• Hashimoto Thyroiditis
• Thyroiditis

• NCT number: NCT01760421
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Completion date: August 2013