Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443651
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-03-02
Brief Title:
A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
An Open-Label Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2017-03
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:
SUNDIAL
Brief Summary:
This is a Phase III open-label study of a total of approximately 560 subjects with active rheumatoid arthritis RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs DMARDs Enrollment in the study was conducted in two stages In Stage I of the study approximately 400 subjects receiving non-biological DMARDs with the exception of methotrexate MTX monotherapy or MTX and leflunomide combination therapy were enrolled In Stage II of the study approximately 160 subjects receiving a Federal Drug Administration-approved biological DMARD at the time of screening were enrolled
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