The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
|ClinicalTrials.gov Identifier: NCT01760421|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hashimoto Thyroiditis||Drug: Hydroxychloroquine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||August 2013|
Receive treatment with hydroxychloroquine
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Other Name: Plaquenil
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760421
|Department of Internal Medicine, National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Tien-Shung Huang, Ph.D.||Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan|