Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793359
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2023-03-07
Brief Title:
Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves Orbitopathy
Sponsor:
Medical University of Sofia
Organization:
Medical University of Sofia
Study Overview
Official Title:
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves Orbitopathy
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves orbitopathy The main questions it aims to answer are
1 Are the two glucocorticoid regimens similarly effective
2 Do the two glucocorticoid regimens have similar safety profile The patients involved are treated with one of the two glucocorticoid regimens Their ocular status therapeutic response and quality of life reassessed during the treatment at its end and 3 month later
1 Are the two glucocorticoid regimens similarly effective
2 Do the two glucocorticoid regimens have similar safety profile The patients involved are treated with one of the two glucocorticoid regimens Their ocular status therapeutic response and quality of life reassessed during the treatment at its end and 3 month later
Detailed Description:
Systemic glucocorticoids are the mainstay of treatment for active moderate-to-severe Graves orbitopathy However there are a number of different glucocorticoid regimens with different total dosage schemes of administration and duration The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves orbitopathy The main questions it aims to answer are
1 Are the two glucocorticoid regimens similarly effective
2 Do the two glucocorticoid regimens have similar safety profile The patients involved are treated with one of the two glucocorticoid regimens The first group is treated with modified monthly regimen including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months with application of 125 mg methylprednisolone intramuscularly once per week between the pulses Total cumulative dose - 55 g duration - 3 months After completion of the venous infusions a low dose peroral glucocorticoid therapy is prescribed for the next 3 months The second group is treated with weekly glucocorticoid regimen 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks Total cumulative dose - 45 g duration - 3 months Patients ocular status and therapeutic response are assessed at 1st 3rd and 6th months quality of life - at 3rd and 6th month
1 Are the two glucocorticoid regimens similarly effective
2 Do the two glucocorticoid regimens have similar safety profile The patients involved are treated with one of the two glucocorticoid regimens The first group is treated with modified monthly regimen including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months with application of 125 mg methylprednisolone intramuscularly once per week between the pulses Total cumulative dose - 55 g duration - 3 months After completion of the venous infusions a low dose peroral glucocorticoid therapy is prescribed for the next 3 months The second group is treated with weekly glucocorticoid regimen 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks Total cumulative dose - 45 g duration - 3 months Patients ocular status and therapeutic response are assessed at 1st 3rd and 6th months quality of life - at 3rd and 6th month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None