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

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 2

Conditions

Anemia

Rheumatoid Arthritis

Treatments

Drug: Epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236678

CR004624

Details and patient eligibility

About

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.

Full description

PROCRIT is not approved for the treatment of anemia of chronic disease in rheumatoid arthritis patients.

Approximately 270 subjects will be participating in this trial, at approximately 25 centers in the United States. Patients will be eligible to participate in this study if hemoglobin (Hb) is <=11.0 g/dL. The hypothesis is that PROCRIT improves fatigue scores in rheumatoid arthritis patients with anemia of chronic disease. If a patient chooses to participate, he/she will be randomized to receive either PROCRIT or placebo on a weekly basis starting at 20,000 units per injection (up to a maximum of 40,000 units).

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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