NCT00123149

Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ortho Biotech Products, L.P. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 (40,000 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 60,000 units once every 2 weeks or 40,000 units once weekly.

Conditions

• Anemia
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Epoetin alfa

Timeline

• Completion: 2007-10-01
• First posted: 2005-07-22
• Last updated: 2016-09-20