Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162266
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2005-09-09
Brief Title:
Abatacept With Methotrexate- Phase IIB
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase IIB Multi-Center Randomized Double-Blind Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
Status:
COMPLETED
Status Verified Date:
2012-05
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:
None
Brief Summary:
This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis RA The secondary objectives were to assess efficacy pharmacodynamic marker activity and immunogenicity of Abatacept combined with Methotrexate
Detailed Description:
All participants who completed the 12-month double-blind study period were eligible to continue in the open-label study Participants received placebo Abatacept 2 mgkg or Abatacept 10 mgkg in the double-blind study Participants receiving placebo in the double-blind study were switched 11 to continued treatment with placebo or Abatacept 2 mgkg Participants receiving Abatacept 2 mgkg or Abatacept 10 mgkg continued at the double-blind study dosage After results from the double-blind period became available all participants were switched to a weight-tiered 10 mgkg dose of Abatacept
Open label study design Single group assignment Single arm Open label
Open label study design Single group assignment Single arm Open label
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