Hydroxychloroquine in Mild Graves' Orbitopathy

NCT05126147 | Recruiting Phase 4 DMC

• 1 other identifier: 202101055MINB
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Graves Ophthalmopathy

Keywords

Graves' ophthalmopathy; Graves' disease; Hydroxychloroquine; Orbital volumetry; GO-QoL questionnaire

Outcome Measures

Primary Outcomes (1)

• The change of ophthalmic outcome

  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".

  at 24 weeks and 48 weeks

Secondary Outcomes (12)

• 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

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine 200mg twice daily for 6 months.

Drug: Hydroxychloroquine

Control

NO INTERVENTION

Observation and active surveillance.

Interventions

Hydroxychloroquine DRUG

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

Also known as: Plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital, Hsin-Chu branch

Hsinchu, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shyang-Rong Shih

CONTACT

+886-2-23123456; srshih@ntu.edu.tw

Hung-Yuan Li

CONTACT

+886-2-23123456; larsli@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 18, 2021
• Study Start: March 21, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available after completed study enrollment.
• Access Criteria: Individual participant data (IPD) sharing is available upon request.

Locations

TW (2)