Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-31 @ 1:01 AM
Study NCT ID:
NCT00583557
Status:
TERMINATED
Last Update Posted:
2013-08-07
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
Sponsor:
Human Genome Sciences Inc.
Organization:
Study Overview
Official Title:
A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision - not related to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
Detailed Description:
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).
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?: