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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02126683
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hashimoto's Thyroiditis	Drug: Hydroxychloroquine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
• Study Start Date: Apr 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plaquenil first Start Plaquenil 200mg BID orally since enrollment Duration: 6 months	Drug: Hydroxychloroquine; Other Names: Plaquenil
Experimental: Plaquenil later Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months	Drug: Hydroxychloroquine; Other Names: Plaquenil

Outcome Measures

Primary Outcome Measures

1. Change of thyroid auto-antibodies [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

Secondary Outcome Measures

1. Change of inflammatory markers [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

2. Change of proinflammatory markers [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

3. Change of goiter size [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Tien-Shang Huang, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT02126683
• Other Study ID Numbers: 201312121MINA
• First Posted: Apr 30, 2014
• Last Update Posted: Apr 30, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by National Taiwan University Hospital: Hashimoto's thyroiditis; Plaquenil
• Additional relevant MeSH terms: Thyroiditis; Hashimoto Disease; Hydroxychloroquine

Study Results

No Results Posted as of Apr 30, 2014