Status:
WITHDRAWN
Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Rheumatoid Arthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00123149
End Date
October 1 2007
Last Update
September 20 2016
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