Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476996
Status:
TERMINATED
Last Update Posted:
2019-08-12
First Post:
2007-05-18
Brief Title:
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Dont Have a Response to Anti-TNF-α Therapy SCRIPT
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 Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was fully completed for this study however the study was terminated during conduct after the primary endpoint analysis was completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCRIPT
Brief Summary:
This study will evaluate the efficacy and safety of ocrelizumab compared with placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy 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 stable doses of either concomitant methotrexate 75-25mgweek or leflunomide 10-20mg po daily and may receive additional DMARDs The treatment period is planned for 48 weeks until primary analysis and then participants will enter the open label phase until the drug is commercialized 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 |
|---|---|---|---|
| 2006-005330-20 | EUDRACT_NUMBER | Genentech | None |
| WA20495 | OTHER | None | None |