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Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

Primary Purpose

Rheumatoid Arthritis

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

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

Eligibility Criteria

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

Inclusion Criteria: Previous enrollment in Immunex protocols No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Total Exposure to Etanercept With Gaps
    Total participant exposure to etanercept (Enbrel) with gaps
    Total Exposure Adjusted Rate of Malignancies
    Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
    Total Exposure Adjusted Rate of Deaths
    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
    Total Exposure Adjusted Rate of Serious Infectious Events
    Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
    Total Exposure Adjusted Rate of Lymphomas
    Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
    Malignancy
    Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
    Lymphoma
    Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
    Serious Infectious Event
    Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.
    Death
    Occurrence of death on study within 30 days of the last dose of etanercept
    Total Exposure Adjusted Rate of Serious Adverse Events
    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)

    Secondary Outcome Measures

    Dosing Period
    Duration of etanercept dosing
    Tender Joint Count
    Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation
    Swollen Joint Count
    Number of swollen joints
    Health Assessment Questionnaire Disability Index
    Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).
    Childhood Health Assessment Questionnaire
    Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).
    C-Reactive Protein
    C-reactive protein at month 12
    ACR20 at Month 3 in Adults
    American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
    JRA DOI 30 at Month 3 in Juveniles
    Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.
    Standardized Incidence Rate for All SEER Cancers
    Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.

    Full Information

    First Posted
    July 26, 2006
    Last Updated
    February 7, 2017
    Sponsor
    Amgen
    Collaborators
    Immunex Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00357903
    Brief Title
    Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
    Official Title
    Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1997 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen
    Collaborators
    Immunex Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Intervention Type
    Biological
    Intervention Name(s)
    Etanercept
    Intervention Description
    Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).
    Primary Outcome Measure Information:
    Title
    Total Exposure to Etanercept With Gaps
    Description
    Total participant exposure to etanercept (Enbrel) with gaps
    Time Frame
    Up to 10 years
    Title
    Total Exposure Adjusted Rate of Malignancies
    Description
    Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
    Time Frame
    Up to 10 years
    Title
    Total Exposure Adjusted Rate of Deaths
    Description
    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
    Time Frame
    Up to 10 years
    Title
    Total Exposure Adjusted Rate of Serious Infectious Events
    Description
    Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
    Time Frame
    Up to 10 years
    Title
    Total Exposure Adjusted Rate of Lymphomas
    Description
    Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
    Time Frame
    Up to 10 years
    Title
    Malignancy
    Description
    Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
    Time Frame
    Up to 10 years
    Title
    Lymphoma
    Description
    Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
    Time Frame
    Up to 10 years
    Title
    Serious Infectious Event
    Description
    Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.
    Time Frame
    Up to 10 years
    Title
    Death
    Description
    Occurrence of death on study within 30 days of the last dose of etanercept
    Time Frame
    Up to 10 years
    Title
    Total Exposure Adjusted Rate of Serious Adverse Events
    Description
    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
    Time Frame
    Up to 10 years
    Secondary Outcome Measure Information:
    Title
    Dosing Period
    Description
    Duration of etanercept dosing
    Time Frame
    Up to 10 years
    Title
    Tender Joint Count
    Description
    Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation
    Time Frame
    Month 12
    Title
    Swollen Joint Count
    Description
    Number of swollen joints
    Time Frame
    Month 12
    Title
    Health Assessment Questionnaire Disability Index
    Description
    Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).
    Time Frame
    Month 12
    Title
    Childhood Health Assessment Questionnaire
    Description
    Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).
    Time Frame
    Month 12
    Title
    C-Reactive Protein
    Description
    C-reactive protein at month 12
    Time Frame
    Month 12
    Title
    ACR20 at Month 3 in Adults
    Description
    American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
    Time Frame
    Baseline and month 3
    Title
    JRA DOI 30 at Month 3 in Juveniles
    Description
    Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.
    Time Frame
    Baseline and month 3
    Title
    Standardized Incidence Rate for All SEER Cancers
    Description
    Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.
    Time Frame
    up to 10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previous enrollment in Immunex protocols No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
    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
    12672185
    Citation
    Fleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, Martin RW, Spencer-Green GT. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003 Apr;30(4):691-6.
    Results Reference
    background
    PubMed Identifier
    12794815
    Citation
    Kremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, Atkins KM, Feng A, Burge DJ. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum. 2003 Jun;48(6):1493-9. doi: 10.1002/art.11142.
    Results Reference
    background
    PubMed Identifier
    12528122
    Citation
    Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ; Pediatric Rheumatology Collaborative Study Group. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003 Jan;48(1):218-26. doi: 10.1002/art.10710.
    Results Reference
    background
    PubMed Identifier
    18438876
    Citation
    Lovell DJ, Reiff A, Ilowite NT, Wallace CA, Chon Y, Lin SL, Baumgartner SW, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008 May;58(5):1496-504. doi: 10.1002/art.23427.
    Results Reference
    background
    PubMed Identifier
    16732547
    Citation
    Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885.
    Results Reference
    background
    PubMed Identifier
    11987981
    Citation
    Moreland LW, Bucy RP, Weinblatt ME, Mohler KM, Spencer-Green GT, Chatham WW. Immune function in patients with rheumatoid arthritis treated with etanercept. Clin Immunol. 2002 Apr;103(1):13-21. doi: 10.1006/clim.2001.5183.
    Results Reference
    background
    PubMed Identifier
    11409115
    Citation
    Moreland LW, Cohen SB, Baumgartner SW, Tindall EA, Bulpitt K, Martin R, Weinblatt M, Taborn J, Weaver A, Burge DJ, Schiff MH. Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis. J Rheumatol. 2001 Jun;28(6):1238-44.
    Results Reference
    background
    PubMed Identifier
    16541481
    Citation
    Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, Whitmore JB, White BW. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006 May;33(5):854-61. Epub 2006 Mar 15.
    Results Reference
    background
    PubMed Identifier
    11352248
    Citation
    Stone JH, Uhlfelder ML, Hellmann DB, Crook S, Bedocs NM, Hoffman GS. Etanercept combined with conventional treatment in Wegener's granulomatosis: a six-month open-label trial to evaluate safety. Arthritis Rheum. 2001 May;44(5):1149-54. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-F.
    Results Reference
    background
    PubMed Identifier
    20957659
    Citation
    Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

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