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The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis

Primary Purpose

Hashimoto's Thyroiditis

Status
Unknown status
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's Thyroiditis focused on measuring Hashimoto's thyroiditis, Plaquenil

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody
  • Euthyroid state by serum free T4 and TSH level within normal limit

Exclusion criteria:

  • Pregnant, planning pregnant within 1 year, or lactating women
  • Renal insufficiency, abnormal liver function test
  • Hematologic diseases: anemia, agranulocytosis, thrombocytopenia
  • G6PD deficiency, porphyria cutaneous tarda
  • Allergy to 4-aminoquinoline compounds
  • Known retinopathy or visual field defect disorders
  • Already receive immunosuppression therapy

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Plaquenil first

Plaquenil later

Arm Description

Start Plaquenil 200mg BID orally since enrollment Duration: 6 months

Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months

Outcomes

Primary Outcome Measures

Change of thyroid auto-antibodies
Change of serum thyroid autoantibodies including anti-TPO antibody and anti-thyroglobulin antibody at baseline, and every 3 months after treatment intervention up to 18 months

Secondary Outcome Measures

Change of inflammatory markers
Change of serum inflammatory markers, including hsCRP and ESR at baseline, and every 3 months after treatment intervention up to 18 months
Change of proinflammatory markers
Change of serum proinflammatory markers and cytokine level at baseline, and every 3 months after treatment intervention up to 18 months
Change of goiter size
Change of thyroid volume measured by ultrasound at baseline, and every 3 months after treatment intervention up to 18 months

Full Information

First Posted
April 28, 2014
Last Updated
April 28, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02126683
Brief Title
The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
Official Title
The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects up to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8 - 3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and antibody-mediated immune processes. Various auto-antibodies may be present against TPO and Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory cytokines in serum of patients with HT, and suggested HT is associated with regulatory T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17 cells. Several studies suggested that pregnant women with HT, even at euthyroid state had higher risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive, anger, and total mood disturbance risk compared to those without HT. Presence of thyroid auto-antibodies is also associated with negative pregnant outcomes including gestational hypertension, late abortion, fetal death, premature delivery and neonatal respiratory distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism. Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and development of goiter and thyroid dysfunction. However, there is no suggested treatment for subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up were suggested. Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells, dendritic cells and monocytes. This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory markers, cytokines, and goiter size in euthyroid women with HT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hashimoto's Thyroiditis
Keywords
Hashimoto's thyroiditis, Plaquenil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plaquenil first
Arm Type
Experimental
Arm Description
Start Plaquenil 200mg BID orally since enrollment Duration: 6 months
Arm Title
Plaquenil later
Arm Type
Experimental
Arm Description
Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Primary Outcome Measure Information:
Title
Change of thyroid auto-antibodies
Description
Change of serum thyroid autoantibodies including anti-TPO antibody and anti-thyroglobulin antibody at baseline, and every 3 months after treatment intervention up to 18 months
Time Frame
Baseline, up to 18 months
Secondary Outcome Measure Information:
Title
Change of inflammatory markers
Description
Change of serum inflammatory markers, including hsCRP and ESR at baseline, and every 3 months after treatment intervention up to 18 months
Time Frame
Baseline, up to 18 months
Title
Change of proinflammatory markers
Description
Change of serum proinflammatory markers and cytokine level at baseline, and every 3 months after treatment intervention up to 18 months
Time Frame
Baseline, up to 18 months
Title
Change of goiter size
Description
Change of thyroid volume measured by ultrasound at baseline, and every 3 months after treatment intervention up to 18 months
Time Frame
Baseline, up to 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody Euthyroid state by serum free T4 and TSH level within normal limit Exclusion criteria: Pregnant, planning pregnant within 1 year, or lactating women Renal insufficiency, abnormal liver function test Hematologic diseases: anemia, agranulocytosis, thrombocytopenia G6PD deficiency, porphyria cutaneous tarda Allergy to 4-aminoquinoline compounds Known retinopathy or visual field defect disorders Already receive immunosuppression therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tien-Shang Huang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis

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