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Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

Primary Purpose

Anemia, Rheumatoid Arthritis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
Ortho Biotech Products, L.P.
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 - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 at Week 1 of the study Women must not be breast feeding during this study period Patients must have completed the double-blind (DB) study (PR03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dL at Week 20 of the DB study 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 or other co-morbid disease that have developed or worsened since enrollment to the double-blind study Planning to be enrolled in any other clinical trial during the course of this study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events during the study period of up to 35 weeks; blood pressure and blood counts measured every 2 weeks up to 35 weeks. For patients who have dose increased to 40,000 units once weekly, hemoglobin levels will be monitored weekly

    Secondary Outcome Measures

    Hemoglobin level measured every two weeks up to 35 weeks; for patients who are receiving 40,000 U QW dosing, Hb levels will be monitored weekly

    Full Information

    First Posted
    July 19, 2005
    Last Updated
    September 19, 2016
    Sponsor
    Ortho Biotech Products, L.P.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00123149
    Brief Title
    Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis
    Official Title
    An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2007 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ortho Biotech Products, L.P.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis
    Detailed Description
    Epoetin alfa is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with chronic kidney disease, information on its effectiveness and long-term safety for treatment of anemia associated with rheumatoid arthritis is limited. This 35-week safety study is an extension of a 20-week, prospective, randomized, double-blind, placebo-controlled, multi-center study that investigates effectiveness of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis. The study hypothesis is that there will be no long-term safety concerns of epoetin alfa administered once every two weeks in rheumatoid arthritis patients with anemia of chronic disease. Patients will receive epoetin alfa injections (40,000 units) under their skin once every 2 weeks for up to 31 weeks. Doses may be adjusted depending on the patients' hemoglobin level up to the maximum of 60,000 units once every 2 weeks or 40,000 units once weekly.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Epoetin alfa
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events during the study period of up to 35 weeks; blood pressure and blood counts measured every 2 weeks up to 35 weeks. For patients who have dose increased to 40,000 units once weekly, hemoglobin levels will be monitored weekly
    Secondary Outcome Measure Information:
    Title
    Hemoglobin level measured every two weeks up to 35 weeks; for patients who are receiving 40,000 U QW dosing, Hb levels will be monitored weekly

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 at Week 1 of the study Women must not be breast feeding during this study period Patients must have completed the double-blind (DB) study (PR03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dL at Week 20 of the DB study 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 or other co-morbid disease that have developed or worsened since enrollment to the double-blind study 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
    Ortho Biotech Products, L.P. Clinical Trial
    Organizational Affiliation
    Ortho Biotech Products, L.P.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

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