Clinical Trial: The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: National Taiwan University Hospital

Current Primary Outcome:

• Anti-TPO antibody [ Time Frame: 6th month after medical treatment ]
  Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
• Anti-thyroglobulin antibody [ Time Frame: 6 months after medical treatment ]
  Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: October 20, 2011
Date Started: October 2011
Date Completion:
Last Updated: April 22, 2014
Last Verified: April 2014