Clinical trial NCT06510114: A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
Official title: Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Graves Ophthalmopathy
Keywords: Hyperthyroidism
Graves Ophthalmopathy
glucocorticoid
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with active moderate-to-severe GO were randomized at a ratio of 1:1 to receive glucocorticoid therapy for 12 weeks on a weekly protocol or daily scheme.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old;
2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;
3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;
4. without receiving immunosuppressive therapy for thyroid eye disease before.

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

Primary outcomes:
measure: the overall response rate at 24 week
timeFrame: 24 week
Secondary outcomes:
measure: Changes of clinical activity score (CAS) from baseline to 24 week
timeFrame: 24 week
measure: changes of quality of life score (QoF-s) from baseline to 24 week
timeFrame: 24 week
measure: changes of exophthalmos from baseline to 24 week
timeFrame: 24 week
measure: changes of width of the eyelid from baseline to 24 week
timeFrame: 24 week
measure: changes of diplopia grade from baseline to 24 week
timeFrame: 24 week
Other outcomes:
measure: Changes of blood pressure from baseline to 24 week
timeFrame: 24 week
measure: Changes of weight from baseline to 24 week
timeFrame: 24 week
measure: Changes of fasting blood glucose from baseline to 24 week
timeFrame: 24 week
measure: Changes of serum low density lipoprotein cholesterol
timeFrame: 24 week
measure: Changes of serum triglyceride
timeFrame: 24 week
Locations:
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Shuo Lin
role: PRINCIPAL_INVESTIGATOR
References: