Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236678
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
Randomized Double-blind Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease ACD Due to Rheumatoid Arthritis Receiving PROCRIT Epoetin Alfa
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to slow enrollment despite protocol amendments to change the entrance criteria
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 research study is to determine fatigue tiredness in subjects with chronic Rheumatoid Arthritis with chronic anemia Fatigue in subjects who get PROCRIT will be compared to fatigue in subjects who get placebo a medically inactive substance The study will also evaluate hemoglobin levels oxygen-carrying protein in red blood cells safety anemia related health concerns vitality arthritis related function and work productivity
Detailed Description:
PROCRIT is not approved for the treatment of anemia of chronic disease in rheumatoid arthritis patients
Approximately 270 subjects will be participating in this trial at approximately 25 centers in the United States Patients will be eligible to participate in this study if hemoglobin Hb is 110 gdL The hypothesis is that PROCRIT improves fatigue scores in rheumatoid arthritis patients with anemia of chronic disease If a patient chooses to participate heshe will be randomized to receive either PROCRIT or placebo on a weekly basis starting at 20000 units per injection up to a maximum of 40000 units
Approximately 270 subjects will be participating in this trial at approximately 25 centers in the United States Patients will be eligible to participate in this study if hemoglobin Hb is 110 gdL The hypothesis is that PROCRIT improves fatigue scores in rheumatoid arthritis patients with anemia of chronic disease If a patient chooses to participate heshe will be randomized to receive either PROCRIT or placebo on a weekly basis starting at 20000 units per injection up to a maximum of 40000 units
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