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

• Status: Withdrawn
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients must have signed an informed consent

• Women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test at Week 1 of the study

• Women must not be breast feeding during this study period

• Patients must have completed the double-blind (DB) study (PR03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dL at Week 20 of the DB study

Exclusion Criteria:

• Uncontrolled hypertension

• Elective surgery, including joint replacement, anticipated to require transfusion during the extension study period

• Thromboembolic event during the double-blind study including acute myocardial infarction, Cerebrovascular accident and/or transient ischemic attack

• Deep vein thrombosis and/or pulmonary embolism

• Uncontrolled psychiatric disease or other co-morbid disease that have developed or worsened since enrollment to the double-blind study

• Planning to be enrolled in any other clinical trial during the course of this study