Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00688103
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2008-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
Sponsor:
Japan Biological Agent Study Integrated Consortium
Organization:
Study Overview
Official Title:
Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan
Status:
COMPLETED
Status Verified Date:
2015-09
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:
JESMR
Brief Summary:
Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.
1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
Detailed Description:
None
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?: