Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine fatigue (tiredness) in subjects with chronic Rheumatoid Arthritis with chronic anemia. Fatigue in subjects who get PROCRIT will be compared to fatigue in subjects who get placebo (a medically inactive substance). The study will also evaluate hemoglobin levels (oxygen-carrying protein in red blood cells), safety, anemia related health concerns, vitality, arthritis related function and work productivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients must have rheumatoid arthritis with chronic anemia. 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

• women must not be breast feeding during this study period.

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

• planning to be enrolled in any other clinical trial during the course of this study