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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02126683
• Other study ID #: 201312121MINA
• Status: Active, not recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: April 28, 2014
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hashimoto Disease
• Hashimoto's Thyroiditis
• Thyroiditis

Intervention

Drug:
• Hydroxychloroquine

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, up to 18 months	No
Secondary	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	Baseline, up to 18 months	No
Secondary	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	Baseline, up to 18 months	No
Secondary	Change of goiter size	Change of thyroid volume measured by ultrasound at baseline, and every 3 months after treatment intervention up to 18 months	Baseline, up to 18 months	No