The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Hashimoto Thyroiditis Clinical Trial

Official title:

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760421
• Other study ID #: 201108006MB
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: April 22, 2014
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

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

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months

Locations

Country	Name	City	State
Taiwan	Department of Internal Medicine, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-TPO antibody	Check anti-TPO antibody 6 months after medical treatment as inflammatory marker	6th month after medical treatment	No
Primary	Anti-thyroglobulin antibody	Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status	6 months after medical treatment	No
Secondary	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	No
Secondary	Thyroid function	Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment	6 months after medical treatment	No
Secondary	Inflammatory cytokines	Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment	6 months after treatment	No