Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789030
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-03-16
Brief Title:
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
Status:
RECRUITING
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:
This study has been designed as a 12-month open-label randomized controlled clinical trial The study aims to compare the efficacy and safety of three treatment strategies in IgG4-RD patients with superficial organ involvement Diprospan plus iguratimod Diprospan plus leflunomide and prednisone plus leflunomide
Detailed Description:
90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 111 ratio patients in group I are treated with Diprospan 1mL im and then with iguratimod 25mg bid patients in group Ⅱ are treated with Diprospan 1mL im and then with leflunomide 10-20mg qd and patients in group Ⅲ are treated with prednisone 20 mg qd and taper to 5mg in 3 months and leflunomide 10-20mg qd All patients will be followed up for 12 months and clinical evaluations laboratory tests image examinations and IgG4-RD responder index RI will be recorded during follow up The primary endpoint is the difference of relapse rate between two groups at 12 months The secondary endpoints are relapse time response rate and side effects
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