The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis | RxWiki

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

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Purpose	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	Hashimoto Thyroiditis
Intervention	Drug: Hydroxychloroquine
Phase	N/A
Sponsor	National Taiwan University Hospital
Responsible Party	National Taiwan University Hospital
ClinicalTrials.gov Identifier	NCT01760421
First Received	October 20, 2011
Last Updated	April 22, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 20, 2011
Last Updated Date	April 22, 2014
Start Date	October 2011
Estimated Primary Completion Date	August 2013
Current Primary Outcome Measures	Anti-TPO antibody [Time Frame: 6th month after medical treatment] [Designated as safety issue: No]Check anti-TPO antibody 6 months after medical treatment as inflammatory marker Anti-thyroglobulin antibody [Time Frame: 6 months after medical treatment] [Designated as safety issue: No]Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
Current Secondary Outcome Measures	Elasticity of thyroid gland [Time Frame: 6 months after medical treatment] [Designated as safety issue: No]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] [Designated as safety issue: No]Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment Inflammatory cytokines [Time Frame: 6 months after treatment] [Designated as safety issue: No]Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment

Descriptive Information[ + expand ][ + ]

Brief Title	The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
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 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 Type	Interventional
Study Phase	N/A
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Hashimoto Thyroiditis
Intervention	Drug: Hydroxychloroquine Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months Other Names: Plaquenil
Study Arm (s)	Experimental: Hydroxychloroquine Receive treatment with hydroxychloroquine

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	August 2013
Estimated Primary Completion Date	December 2012
Eligibility Criteria	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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Taiwan

Administrative Information[ + expand ][ + ]

NCT Number	NCT01760421
Other Study ID Numbers	201108006MB
Has Data Monitoring Committee	No
Information Provided By	National Taiwan University Hospital
Study Sponsor	National Taiwan University Hospital
Collaborators	Not Provided
Investigators	Study Chair: Tien-Shung Huang, Ph.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
Verification Date	April 2014

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