Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123149
Status:
WITHDRAWN
Last Update Posted:
2016-09-20
First Post:
2005-07-19
Brief Title:
Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
An Open-Label OL Extension Study to Assess Safety of PROCRIT Epoetin Alfa in Patients With Anemia of Chronic Disease ACD Due to Rheumatoid Arthritis RA
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis
Detailed Description:
Epoetin alfa is an analogue of erythropoetin a hormone secreted by kidneys known to stimulate red blood cell production Although epoetin alfa has been known to be effective in treatment of anemia associated with chronic kidney disease information on its effectiveness and long-term safety for treatment of anemia associated with rheumatoid arthritis is limited This 35-week safety study is an extension of a 20-week prospective randomized double-blind placebo-controlled multi-center study that investigates effectiveness of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis The study hypothesis is that there will be no long-term safety concerns of epoetin alfa administered once every two weeks in rheumatoid arthritis patients with anemia of chronic disease Patients will receive epoetin alfa injections 40000 units under their skin once every 2 weeks for up to 31 weeks Doses may be adjusted depending on the patients hemoglobin level up to the maximum of 60000 units once every 2 weeks or 40000 units once weekly
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