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

NCT02126683 | Unknown DMC

• 1 other identifier: 201312121MINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hashimoto's Thyroiditis

Keywords

Hashimoto's thyroiditis; Plaquenil

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change of inflammatory markers

  Baseline, up to 18 months

• Change of proinflammatory markers

  Baseline, up to 18 months

• Change of goiter size

  Baseline, up to 18 months

Study Arms (2)

Plaquenil first

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Plaquenil later

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Also known as: Plaquenil

Plaquenil first; Plaquenil later

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tien-Shang Huang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

TW (1)