Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299104
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2006-03-02
Brief Title:
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Randomized Phase 3 Controlled Double-Blind Parallel-Group Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate MTX Compared to MTX Alone in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
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:
IMAGE
Brief Summary:
This is a phase III randomized controlled double-blind parallel group international study in approximately 750 patients with active Rheumatoid Arthritis RA who are naive to Methotrexate MTX therapy Rheumatoid Factor RF-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WA17047 | None | None | None |