Status:
TERMINATED
Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 fatigu...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00236678
Start Date
July 1 2004
End Date
January 1 2006
Last Update
June 10 2011
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