Hashimoto's Thyroiditis Clinical Trial
Official title:
The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02190214 -
Thyroid Disorders in Malaysia: A Nationwide Multicentre Study
|
N/A |