Hydroxychloroquine in Mild Graves' Orbitopathy

Официальное название

A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

Обзор

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

Подробное описание

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.

Вмешательства

• Препарат Hydroxychloroquine
  Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.

Первичные конечные точки

• The change of ophthalmic outcome [Срок оценки: at 24 weeks and 48 weeks]

Вторичные конечные точки (12)

• The change of quality of life (GO-QoL) [Срок оценки: at 24 weeks and 48 weeks]
• The change of muscle volume (cm^3) on computed tomography [Срок оценки: at 24 weeks and 48 weeks]
• The change of fat volume (cm^3) on computed tomography [Срок оценки: at 24 weeks and 48 weeks]
• The change of orbital volume (cm^3) on computed tomography [Срок оценки: at 24 weeks and 48 weeks]
• The change of muscle density on computed tomography [Срок оценки: at 24 weeks and 48 weeks]
• The change of fat density on computed tomography [Срок оценки: at 24 weeks and 48 weeks]
• The change of diplopia score [Срок оценки: at 24 weeks and 48 weeks]
• The change of clinical activity score (CAS) [Срок оценки: at 24 weeks and 48 weeks]
• The change of visual acuity [Срок оценки: at 24 weeks and 48 weeks]
• The change of antithyroid peroxidase antibody (anti-TPO) (IU/mL) [Срок оценки: at 24 weeks and 48 weeks]
• The change of thyroglobulin antibody (TA) (IU/mL) [Срок оценки: at 24 weeks and 48 weeks]
• The change of thyrotropin-binding inhibiting immunoglobulin (TBII) (%). [Срок оценки: at 24 weeks and 48 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• National Taiwan University Hospital, Hsin-Chu branch — Hsinchu
• National Taiwan University Hospital — Taipei

Публикации

• Lin CH, Wei YH, Lu JY, Li HY, Lee CW, Yang CY, Chang CH, Wu WC, Wang CY, Shih SR. A randomized controlled trial on the effect of hydroxychloroquine in mild Graves' orbitopathy (GO-HCQ): study protocol. Trials. 2025 Aug 4;26(1):272. doi: 10.1186/s13063-025-09002-6. PMID 40760017

Идентификаторы

NCT: NCT05126147 · 202101055MINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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