Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01198002
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated not based on safety concerns, but due to insufficient efficacy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLEX M
Brief Summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
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?: