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

Sponsored by:	Ortho Biotech Products, L.P.
Information provided by:	Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:	NCT00123149

Purpose

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

MedlinePlus related topics: Anemia Coping with Chronic Illness Rheumatoid Arthritis

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

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)

Further study details as provided by Ortho Biotech Products, L.P.:

Primary Outcome Measures:

Incidence of adverse events during the study period of up to 35 weeks; blood pressure and blood counts measured every 2 weeks up to 35 weeks. For patients who have dose increased to 40,000 units once weekly, hemoglobin levels will be monitored weekly

Secondary Outcome Measures:

Hemoglobin level measured every two weeks up to 35 weeks; for patients who are receiving 40,000 U QW dosing, Hb levels will be monitored weekly

Estimated Enrollment:

200

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123149

Sponsors and Collaborators

Ortho Biotech Products, L.P.

Investigators

Study Director:

Ortho Biotech Products, L.P. Clinical Trial

Ortho Biotech Products, L.P.

More Information

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR002461
Study First Received:	July 19, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00123149
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ortho Biotech Products, L.P.:

Rheumatoid arthritis
Anemia
Hemoglobin level

Study placed in the following topic categories:

Epoetin Alfa
Autoimmune Diseases
Musculoskeletal Diseases
Hematologic Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Anemia
Arthritis, Rheumatoid
Chronic Disease
Rheumatic Diseases

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Immune System Diseases
Hematinics

Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009