Study Stopped
This study was terminated due to slow enrollment, despite protocol amendments to change the entrance criteria.
Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT
A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT� (Epoetin Alfa)
1 other identifier
interventional
29
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJune 10, 2011
March 1, 2010
October 7, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess changes in fatigue in patients at least 18 years old with chronic rheumatoid arthritis (RA) and chronic anemia (Hb < 11.0 g/dL) due to ACD receiving weekly s.c. doses of PROCRIT versus placebo.
Secondary Outcomes (1)
Hb response; changes in anemia associated health concerns; changes in vitality; changes in arthritis related function
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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
- planning to be enrolled in any other clinical trial during the course of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
July 1, 2004
Study Completion
January 1, 2006
Last Updated
June 10, 2011
Record last verified: 2010-03