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The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

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ClinicalTrials.gov Identifier: NCT01760421
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hashimoto Thyroiditis Drug: Hydroxychloroquine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine
Receive treatment with hydroxychloroquine
 Drug: Hydroxychloroquine
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Other Name: Plaquenil


Outcome Measures
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Primary Outcome Measures :
  1. Anti-TPO antibody [ Time Frame: 6th month after medical treatment ]
    Check anti-TPO antibody 6 months after medical treatment as inflammatory marker

  2. Anti-thyroglobulin antibody [ Time Frame: 6 months after medical treatment ]
    Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status


Secondary Outcome Measures :
  1. Elasticity of thyroid gland [ Time Frame: 6 months after medical treatment ]
    Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid

  2. Thyroid function [ Time Frame: 6 months after medical treatment ]
    Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment

  3. Inflammatory cytokines [ Time Frame: 6 months after treatment ]
    Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760421


Locations
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Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Tien-Shung Huang, Ph.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01760421     History of Changes
Other Study ID Numbers: 201108006MB
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Thyroiditis
Hashimoto Disease
Thyroid Diseases
Endocrine System Diseases
Thyroiditis, Autoimmune
Hydroxychloroquine
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents