The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

NCT ID: NCT01760421

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-08-31

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.

Conditions

Hashimoto Thyroiditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine

Receive treatment with hydroxychloroquine

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

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

Interventions

Hydroxychloroquine

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

Intervention Type: DRUG

Other Intervention Names

Plaquenil

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tien-Shung Huang, Ph.D.

Role: STUDY_CHAIR

Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

Locations

Department of Internal Medicine, National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

201108006MB

Identifier Type: -

Identifier Source: org_study_id