Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195663
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2005-09-13
Brief Title:
Efficacy and Safety of Adalimumab and Methotrexate MTX Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
Sponsor:
AbbVie prior sponsor Abbott
Organization:
AbbVie
Study Overview
Official Title:
A Prospective Multi-Centre Randomised Double-Blind Active Comparator-Controlled Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis PREMIER
Status:
COMPLETED
Status Verified Date:
2013-06
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:
PREMIER
Brief Summary:
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis RA and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years
Detailed Description:
This study had an initial 2-year double-blind treatment period followed by an 8-year open-label extension period for a total of up to 10 years study duration The study was designed to assess the potential of adalimumab methotrexate to improve signs and symptoms of disease and to inhibit radiographic progression in patients with recent onset disease duration less than 3 years rheumatoid arthritis not previously treated with methotrexate Adalimumab is a human anti-tumor necrosis factor TNF monoclonal antibody
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