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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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, produ

Detailed Summary:
Sponsor: National Taiwan University Hospital

Current Primary Outcome: Change of thyroid auto-antibodies [ Time Frame: Baseline, up to 18 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of inflammatory markers [ Time Frame: Baseline, up to 18 months ]
    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 [ Time Frame: Baseline, up to 18 months ]
    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 [ Time Frame: Baseline, up to 18 months ]
    Change of thyroid volume measured by ultrasound at baseline, and every 3 months after treatment intervention up to 18 months


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: April 28, 2014
Date Started: April 2014
Date Completion: September 2016
Last Updated: April 28, 2014
Last Verified: April 2014