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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00123149
First received: July 19, 2005
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  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
Anemia
Rheumatoid Arthritis
 Drug: Epoetin alfa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

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
Estimated Study Completion Date: October 2007
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

No publications provided

ClinicalTrials.gov Identifier: NCT00123149     History of Changes
Other Study ID Numbers: CR002461
Study First Received: July 19, 2005
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho Biotech Products, L.P.:
Anemia
Rheumatoid arthritis
Hemoglobin level

Additional relevant MeSH terms:
Anemia
Chronic Disease
Arthritis
Arthritis, Rheumatoid
Hematologic Diseases
Disease Attributes
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013