Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048932
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2002-11-11
Brief Title:
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-11
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:
The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications
Detailed Description:
This was a multinational multicenter randomized double-blind 2-arm parallel-dosing designed study The treatment period was 12 months Eligible participants were randomized to 1 of 2 treatment groups abatacept fixed dose approximating 10 mgkg based on participants body weight 500 mg for participants weighing 60kg 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing 100 kg monthly or placebo intravenous IV infusion All participants continued their background therapyies for rheumatoid arthritis RA non-biologic or biologic disease-modifying drugs DMARDs or combination throughout the double-blind treatment period Double-blind study medication abatacept or placebo was administered on Days 1 15 29 and every 28 days thereafter for a total of 14 doses
All participants who completed the 12-month double-blind study period Day 1 through Day 365 were eligible to continue into the open-label period All eligible participants active or placebo were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mgkg based on their Day 365 body weight Participants continued to receive infusions every 28 days
All participants who completed the 12-month double-blind study period Day 1 through Day 365 were eligible to continue into the open-label period All eligible participants active or placebo were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mgkg based on their Day 365 body weight Participants continued to receive infusions every 28 days
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