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

NCT00123149 | Withdrawn Phase 2

• 1 other identifier: CR002461
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anemia; Rheumatoid Arthritis

Keywords

Anemia; Rheumatoid arthritis; Hemoglobin level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

MeSH Terms

Conditions

Anemia; Arthritis, Rheumatoid

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Completion: October 1, 2007
• Last Updated: September 20, 2016

Record last verified: 2011-07