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Treatment for Subjects With Active Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Etanercept Liquid
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, RA, etanercept, Immunex, Amgen

Eligibility Criteria

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

Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate: AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL; Platelet count greater than or equal to 125,000/cm3; White blood cell count (WBC) greater than or equal to 3500 cells/cm3; Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.

    Secondary Outcome Measures

    Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
    Measurements from safety laboratory assessments.

    Full Information

    First Posted
    May 16, 2005
    Last Updated
    April 24, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00110903
    Brief Title
    Treatment for Subjects With Active Rheumatoid Arthritis (RA)
    Official Title
    Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid arthritis, RA, etanercept, Immunex, Amgen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Etanercept Liquid
    Primary Outcome Measure Information:
    Title
    Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
    Title
    Measurements from safety laboratory assessments.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate: AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL; Platelet count greater than or equal to 125,000/cm3; White blood cell count (WBC) greater than or equal to 3500 cells/cm3; Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17417989
    Citation
    Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, Zhou L, Peloso P. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2007 Jan-Feb;25(1):40-6.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    Treatment for Subjects With Active Rheumatoid Arthritis (RA)

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