A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: methylprednisolone(daily scheme), methylprednisolone(weekly scheme).
- Who it may be relevant to
- Registry conditions: Graves Ophthalmopathy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial
Overview
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.
Interventions
- Drug methylprednisolone(daily scheme)
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. - Drug methylprednisolone(weekly scheme)
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.
Primary outcome measures
- the overall response rate at 24 week [Time frame: 24 week]
Secondary outcome measures (5)
- Changes of clinical activity score (CAS) from baseline to 24 week [Time frame: 24 week]
- changes of quality of life score (QoF-s) from baseline to 24 week [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]
Eligibility criteria
Inclusion criteria
- Age 18-65 years old;
- diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;
- Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06510114 · RG2024-016-01