Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234884
Status:
COMPLETED
Last Update Posted:
2011-09-30
First Post:
2005-09-16
Brief Title:
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Five-year Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 ReAct and Subsequently Prescribed Humira
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:
ReAlise
Brief Summary:
The purpose of this observational study was to observe and assess the long term use safety and effectiveness of adalimumab in a normal clinical setting
Detailed Description:
This was a multicenter uncontrolled 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis RA who had received adalimumab for at least 3 months in NCT00448383 Study M02-497 an interventional study that ended when adalimumab became commercially available for the treatment of RA Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 Study M02-497 ended and been prescribed commercial adalimumab and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 Study M03-634
Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice and were free to determine the appropriate therapy for each patient Concomitant treatment with disease-modifying antirheumatic drugs DMARDs including methotrexate could be continued while receiving adalimumab If treatment with adalimumab was permanently discontinued for any reason participants were discontinued from the study and the reason was recorded Investigators were asked to record adverse events up to 3 months after last administration of adalimumab
Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice and were free to determine the appropriate therapy for each patient Concomitant treatment with disease-modifying antirheumatic drugs DMARDs including methotrexate could be continued while receiving adalimumab If treatment with adalimumab was permanently discontinued for any reason participants were discontinued from the study and the reason was recorded Investigators were asked to record adverse events up to 3 months after last administration of adalimumab
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