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The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01760421
First received: October 20, 2011
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Hashimoto Thyroiditis
 Drug: Hydroxychloroquine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Anti-TPO antibody [ Time Frame: 6th month after medical treatment ] [ Designated as safety issue: No ]
    Check anti-TPO antibody 6 months after medical treatment as inflammatory marker

  • Anti-thyroglobulin antibody [ Time Frame: 6 months after medical treatment ] [ Designated as safety issue: No ]
    Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status


Secondary Outcome Measures:
  • Elasticity of thyroid gland [ Time Frame: 6 months after medical treatment ] [ Designated as safety issue: No ]
    Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid

  • Thyroid function [ Time Frame: 6 months after medical treatment ] [ Designated as safety issue: No ]
    Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment

  • Inflammatory cytokines [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxychloroquine
Receive treatment with hydroxychloroquine
 Drug: Hydroxychloroquine
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Other Name: Plaquenil

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760421

Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Tien-Shung Huang, Ph.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01760421     History of Changes
Other Study ID Numbers: 201108006MB
Study First Received: October 20, 2011
Last Updated: March 13, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Thyroiditis
Hashimoto Disease
Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013