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

Primary Purpose

Anemia, Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Rheumatoid arthritis, Hemoglobin level

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    Hb response; changes in anemia associated health concerns; changes in vitality; changes in arthritis related function

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236678
    Brief Title
    Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    This study was terminated due to slow enrollment, despite protocol amendments to change the entrance criteria.
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Rheumatoid Arthritis
    Keywords
    Anemia, Rheumatoid arthritis, Hemoglobin level

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Epoetin alfa
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Hb response; changes in anemia associated health concerns; changes in vitality; changes in arthritis related function

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=609&filename=CR004624_CSR.pdf
    Description
    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)

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

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