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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

Tracking Information
First Submitted Date  ICMJE October 20, 2011
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date April 23, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Anti-TPO antibody [ Time Frame: 6th month after medical treatment ]
    Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
  • Anti-thyroglobulin antibody [ Time Frame: 6 months after medical treatment ]
    Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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
  • Thyroid function [ Time Frame: 6 months after medical treatment ]
    Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment
  • Inflammatory cytokines [ Time Frame: 6 months after treatment ]
    Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
Official Title  ICMJE The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hashimoto Thyroiditis
Intervention  ICMJE Drug: Hydroxychloroquine
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Other Name: Plaquenil
Study Arms  ICMJE Experimental: Hydroxychloroquine
Receive treatment with hydroxychloroquine
Intervention: Drug: Hydroxychloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
60
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760421
Other Study ID Numbers  ICMJE 201108006MB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tien-Shung Huang, Ph.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
PRS Account National Taiwan University Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP