Hydroxychloroquine in Mild Graves' Orbitopathy
ConditionGraves Ophthalmopathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Taiwan University Hospital
About this trial
This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hydroxychloroquine
DrugCompare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: HydroxychloroquineExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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".
Time frame
at 24 weeks and 48 weeksSecondary outcomes
1
The change of quality of life (GO-QoL)
The outcome is grading as improvement, stable and deterioration. Improvement is defined if there are more than 6 points increase in any of the category in GO-QoL. Deterioration is defined if there are more than 6 points decrease in any of the category in GO-QoL. Stable is defined if none of above criteria is achieved.
Time frame
at 24 weeks and 48 weeks2
The change of muscle volume (cm^3) on computed tomography
Change of muscle volume on noncontrast orbital CT
Time frame
at 24 weeks and 48 weeks3
The change of fat volume (cm^3) on computed tomography
Change of fat volume on noncontrast orbital CT
Time frame
at 24 weeks and 48 weeks4
The change of orbital volume (cm^3) on computed tomography
Change of orbital volume on noncontrast orbital CT
Time frame
at 24 weeks and 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov