NCT Number: NCT06510114
Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 4
The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months
0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks.
Other names: prednisone
0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks.
Time frame: 24 week
"Response" was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none).
Time frame: 24 week
changes of clinical activity score (CAS) from baseline to 24 week
Time frame: 24 week
changes of quality of life score (QoF-s )
Time frame: 24 week
changes of exophthalmos from baseline to 24 week
Time frame: 24 week
changes of width of the eyelid from baseline to 24 week
Time frame: 24 week
changes of diplopia grade from baseline to 24 week
Time frame: 24 week
Changes of blood pressure from baseline to 24 week
Time frame: 24 week
Changes of weight from baseline to 24 week
Time frame: 24 week
Changes of fasting blood glucose from baseline to 24 week
Time frame: 24 week
Changes of low density lipoprotein cholesterol from baseline to 24 week
Time frame: 24 week
Changes of serum triglyceride from baseline to 24 week
Contact information is provided by the study sponsor or research team.
Third Affiliated Hospital, Sun Yat-Sen University
Other
Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01727973
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Guangzhou, Guangdong, China
View Trial DetailsNCT07623993
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
San Jose, California, United States
View Trial DetailsNCT07594912
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Guangzhou, Guangdong, China
View Trial DetailsNCT07716397
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Shanghai, Huangpu District, China
View Trial Details