The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
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|ClinicalTrials.gov Identifier: NCT02126683|
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : April 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hashimoto's Thyroiditis||Drug: Hydroxychloroquine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Plaquenil first
Start Plaquenil 200mg BID orally since enrollment Duration: 6 months
Other Name: Plaquenil
Experimental: Plaquenil later
Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months
Other Name: Plaquenil
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126683
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Tien-Shang Huang||National Taiwan University Hospital|