Hashimoto's ThyroiditisNCT02126683
The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
A study testing Hydroxychloroquine in people with Hashimoto's Thyroiditis, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hashimoto's Thyroiditis
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Hydroxychloroquine
- Keywords
- Hashimoto's thyroiditis, Plaquenil
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
| Study group | Role | What they receive |
|---|---|---|
| Plaquenil first | Experimental | Start Plaquenil 200mg BID orally since enrollment Duration: 6 months Receives: Drug: Hydroxychloroquine |
| Plaquenil later | Experimental | Start Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, up to 18 months
Secondary outcomes (3)
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
Measured: Baseline, up to 18 months
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
Measured: Baseline, up to 18 months
Change of goiter size
Change of thyroid volume measured by ultrasound at baseline, and every 3 months after treatment intervention up to 18 months
Measured: Baseline, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto's ThyroiditisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tien-Shang Huang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126683
- Sponsor's protocol ID
- 201312121MINA
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis
- ClinicalTrials.gov ID
- NCT02126683
- Acronym / sponsor ID
- 201312121MINA
- Conditions
- Hashimoto's Thyroiditis
- Keywords
- Hashimoto's thyroiditis, Plaquenil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaquenil first | Experimental | Drug: HydroxychloroquineStart Plaquenil 200mg BID orally since enrollment Duration: 6 months |
| Plaquenil later | Experimental | Drug: HydroxychloroquineStart Plaquenil 200mg BID orally since the 25th week after enrollment Duration: 6 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: Plaquenil | Drug | Plaquenil first, Plaquenil later |
Primary outcome
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
3 secondary outcomes
Change of inflammatory markers
Time frame: Baseline, up to 18 months
Change of proinflammatory markers
Time frame: Baseline, up to 18 months
Change of goiter size
Time frame: Baseline, up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tien-Shang Huang principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine in people with Hashimoto's Thyroiditis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of thyroid auto-antibodies (time frame: Baseline, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.