Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-10 @ 3:21 PM
Study NCT ID:
NCT02202395
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2014-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Organization:
Study Overview
Official Title:
A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Status:
COMPLETED
Status Verified Date:
2017-06
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:
T8
Brief Summary:
The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS) in active rheumatoid arthritis patients with an inadequate response to methotrexate.
Detailed Description:
1. Investigate the efficacy of Hydroxytriptolide in active RA patients
2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system.
3. Population PK study.
2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system.
3. Population PK study.
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?: