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Sponsored by: |
Ortho Biotech Products, L.P. |
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Information provided by: | Ortho Biotech Products, L.P. |
ClinicalTrials.gov Identifier: | NCT00123149 |
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
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis Anemia |
Drug: Epoetin alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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) |
Estimated Enrollment: | 200 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR002461 |
Study First Received: | July 19, 2005 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00123149 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Rheumatoid arthritis Anemia Hemoglobin level |
Epoetin Alfa Autoimmune Diseases Musculoskeletal Diseases Hematinics Hematologic Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Anemia Arthritis, Rheumatoid Chronic Disease Rheumatic Diseases |
Epoetin Alfa Disease Attributes Autoimmune Diseases Immune System Diseases Hematinics Hematologic Diseases Joint Diseases Hematologic Agents Anemia |
Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions Pathologic Processes Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Chronic Disease |