Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852171
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-04-23
Brief Title:
Baricitinib in Idiopathic Granulomatous Mastitis
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
A Prospective Open-label Single-arm Clinical Study of the Efficacy of Baricitinib for Idiopathic Granulomatous Mastitis in a Single Institution
Status:
RECRUITING
Status Verified Date:
2023-04
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:
This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis and clarify the clinical classification and corresponding markers
Detailed Description:
This study is aim to explore the mechanism of baricitinib in regulating the occurrence and development of idiopathic granulomatous mastitis as well as the clinical classification and potential markers of idiopathic granulomatous mastitis The target population of interest in this study is patients with non-lactating mastitis which requires core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration Measurable lesions are required The primary end point was the clinical complete remission rate and the secondary end point was the degree of focus reduction the recurrence rate within 12 months after drug withdrawal the degree of inflammation markers decline and the toxicity and side effects of the drug
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