Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406419
Status:
TERMINATED
Last Update Posted:
2020-11-27
First Post:
2006-11-30
Brief Title:
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment STAGE
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Randomized Double-Blind Parallel Group International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on analysis of results and consideration of available treatments the overall benefit to risk profile of ocrelizumab was not favorable in RA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAGE
Brief Summary:
This study will evaluate the efficacy and safety of ocrelizumab compared with placebo in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate Patients will be randomized to receive placebo 200mg of intravenous ocrelizumab or 500mg of iv ocrelizumab on Days 1 and 15 A repeat course of iv treatment will be administered at Weeks 24 and 26 All patients will receive 75mg - 25mgweek concomitant methotrexate at a stable dose The anticipated time on study treatment is 1-2 years Target sample size is 1000
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 |
|---|---|---|---|
| WA20494 | None | None | None |