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Trial record 2 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Plaquenil first
Start Plaquenil 200mg BID orally since enrollment Duration: 6 months
Drug: Hydroxychloroquine
Other Name: Plaquenil

Experimental: Plaquenil later
Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months
Drug: Hydroxychloroquine
Other Name: Plaquenil




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Tien-Shang Huang National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02126683     History of Changes
Other Study ID Numbers: 201312121MINA
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by National Taiwan University Hospital:
Hashimoto's thyroiditis
Plaquenil
Additional relevant MeSH terms:
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Hashimoto Disease
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Thyroiditis, Autoimmune
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents