The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

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.

Study Overview

• Status: Completed
• Conditions: Hashimoto Thyroiditis
• Intervention / Treatment: Drug: Hydroxychloroquine

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Department of Internal Medicine, National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxychloroquine; Receive treatment with hydroxychloroquine	Drug: Hydroxychloroquine; Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months; Other Names: Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-TPO antibody	Check anti-TPO antibody 6 months after medical treatment as inflammatory marker	6th month after medical treatment
Anti-thyroglobulin antibody	Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status	6 months after medical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Thyroid function	Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment	6 months after medical treatment
Inflammatory cytokines	Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment	6 months after treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Tien-Shung Huang, Ph.D., Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 22, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Hashimoto Disease; Thyroiditis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 201108006MB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No