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The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Primary Purpose

Hashimoto Thyroiditis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hashimoto Thyroiditis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydroxychloroquine

Arm Description

Receive treatment with hydroxychloroquine

Outcomes

Primary Outcome Measures

Anti-TPO antibody
Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
Anti-thyroglobulin antibody
Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status

Secondary Outcome Measures

Elasticity of thyroid gland
Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid
Thyroid function
Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment
Inflammatory cytokines
Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment

Full Information

First Posted
October 20, 2011
Last Updated
April 22, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01760421
Brief Title
The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
Official Title
The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hashimoto Thyroiditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Receive treatment with hydroxychloroquine
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
Primary Outcome Measure Information:
Title
Anti-TPO antibody
Description
Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
Time Frame
6th month after medical treatment
Title
Anti-thyroglobulin antibody
Description
Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
Time Frame
6 months after medical treatment
Secondary Outcome Measure Information:
Title
Elasticity of thyroid gland
Description
Measure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid
Time Frame
6 months after medical treatment
Title
Thyroid function
Description
Measure serum free T4 and thyroid-stimulating hormone level 6 months after treatment
Time Frame
6 months after medical treatment
Title
Inflammatory cytokines
Description
Measure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tien-Shung Huang, Ph.D.
Organizational Affiliation
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Internal Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

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