The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
- Registration Number
- NCT01760421
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Hashimoto's thyroiditis
- Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit)
- Never receive immunomodulators or immunosuppressants
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydroxychloroquine Hydroxychloroquine Receive treatment with hydroxychloroquine
- Primary Outcome Measures
Name Time Method Anti-TPO antibody 6th month after medical treatment Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
Anti-thyroglobulin antibody 6 months after medical treatment Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
- Secondary Outcome Measures
Name Time Method Elasticity of thyroid gland 6 months after medical treatment Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid
Thyroid function 6 months after medical treatment Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment
Inflammatory cytokines 6 months after treatment Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment
Trial Locations
- Locations (1)
Department of Internal Medicine, National Taiwan University Hospital
🇨🇳Taipei, Taiwan