Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195702
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2005-09-13
Brief Title:
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate
Status:
COMPLETED
Status Verified Date:
2011-08
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 the study was to assess the safety immunogenicity and clinical efficacy of adalimumab compared with placebo during double-blind phase and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab during open-label extension phase in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy
Detailed Description:
This was a 10-year study which had an initial 52-week double-blind placebo-controlled phase followed by an open-label extension phase up to 9 years in duration Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study the Intent-to-Treat ITT population
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