A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- The change of ophthalmic outcome
研究概览
简要总结
This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
详细描述
Graves' orbitopathy (GO) is one of the common manifestations of Graves' disease (GD), which results in proptosis, eyelid retraction, soft tissue swelling, diplopia or even visual acuity impairment. In addition, mental health and quality of life are often affected. In current guidelines, limited treatment options are suggested for patients with mild GO.
Recently, cell study revealed that there are multiple effects of hydroxychloroquine (HCQ) on orbital fibroblasts in patients with mild GO, including suppression of cell proliferation, adipogenesis and production of hyaluronic acid, which poses a great potential in the treatment of mild GO clinically. This randomized controlled trial is aimed to investigate the effects of HCQ in patients with mild GO on the effects of ophthalmic outcomes, quality of life, orbital volumetry on orbital computed tomography, serum inflammatory and fibrosis markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist.
- •No previous treatment of GO except for eyedrops
- •Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months.
排除标准
- •Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist.
- •Pregnancy
- •Drug or alcohol abuse
- •Unable to comply with the study protocol
- •Unable to obtain informed consent
- •Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment
- •History of side effects of hydroxychloroquine
- •History of retinopathy
- •Renal dysfunction (estimated glomerular filtration rate (eGFR) < 60ml/min)
- •Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit)
- •Anemia (hemoglobin (Hb) < 10g/dl)
- •Neutropenia (absolute neutrophil count < 100/uL)
- •Thrombocytopenia (platelet (PLT) < 150000/uL)
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Porphyria cutaneous tarda
- •Allergy to 4-aminoquinoline
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine 200mg twice daily for 6 months.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
The change of ophthalmic outcome
时间窗: at 24 weeks and 48 weeks
The ophthalmic outcome is a composite outcome which includes three components: eyelid aperture, soft tissue involvement and exophthalmos. The outcome is defined as "improvement" if any of the three components improves without deterioration of any other components. The outcome of "deterioration" is defined if upgrading of soft tissue involvement or evidence of worsening sight or optic nerve compression. The outcome of "stable" is defined if the ophthalmic outcome does not fit the definition of "improvement" or "deterioration".
次要结局
- The change of quality of life (GO-QoL)(at 24 weeks and 48 weeks)
- The change of muscle volume (cm^3) on computed tomography(at 24 weeks and 48 weeks)
- The change of fat volume (cm^3) on computed tomography(at 24 weeks and 48 weeks)
- The change of orbital volume (cm^3) on computed tomography(at 24 weeks and 48 weeks)
- The change of muscle density on computed tomography(at 24 weeks and 48 weeks)
- The change of fat density on computed tomography(at 24 weeks and 48 weeks)
- The change of diplopia score(at 24 weeks and 48 weeks)
- The change of clinical activity score (CAS)(at 24 weeks and 48 weeks)
- The change of visual acuity(at 24 weeks and 48 weeks)
- The change of antithyroid peroxidase antibody (anti-TPO) (IU/mL)(at 24 weeks and 48 weeks)
- The change of thyroglobulin antibody (TA) (IU/mL)(at 24 weeks and 48 weeks)
- The change of thyrotropin-binding inhibiting immunoglobulin (TBII) (%).(at 24 weeks and 48 weeks)