Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02703194
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2016-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leflunomide for Maintenance of Remission in IgG4 Related Disease
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease
Status:
COMPLETED
Status Verified Date:
2019-03
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 study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.
Detailed Description:
The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: