Clincosm LogoSign in Get a demo

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01760421
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
22
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
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 :
Oct 1, 2011
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Anti-TPO antibody [6th month after medical treatment]

      Check anti-TPO antibody 6 months after medical treatment as inflammatory marker

    2. Anti-thyroglobulin antibody [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 [6 months after medical treatment]

      Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid

    2. Thyroid function [6 months after medical treatment]

      Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment

    3. Inflammatory cytokines [6 months after treatment]

      Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01760421
    Other Study ID Numbers:
    • 201108006MB
    First Posted:
    Jan 4, 2013
    Last Update Posted:
    Apr 23, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Thyroiditis
    Hashimoto Disease
    Hydroxychloroquine

    Study Results

    No Results Posted as of Apr 23, 2014