NCT00356590

Brief Summary

This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 1998

Longer than P75 for phase_3 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 8, 2010

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

10 years

First QC Date

July 24, 2006

Results QC Date

November 5, 2010

Last Update Submit

May 10, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisEtanerceptLong-term SafetyEnbrel

Outcome Measures

Primary Outcomes (10)

  • Total Exposure to Etanercept With Gaps

    Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.

    Up to 8 years

  • 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

    Up to 8 years

  • Total Exposure-Adjusted Rate of Deaths

    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

    Up to 8 years

  • 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

    Up to 8 years

  • 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

    Up to 8 years

  • Malignancy

    Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept

    Up to 8 years

  • Lymphoma

    Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept

    Up to 8 years

  • 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

    Up to 8 years

  • Total Exposure Adjusted Rate of Serious Adverse Events

    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)

    Up to 8 years

  • Death

    Death of the participant on study up to 30 days after the last dose of etanercept

    Up to 8 years

Secondary Outcomes (19)

  • ACR20 Response at Month 3

    Baseline and month 3

  • Dosing Period

    Up to 8 years

  • ACR20 Response at Month 12

    Baseline and month 12

  • ACR50 Response at Month 12

    Baseline and month 12

  • ACR70 Response at Month 12

    Baseline and month 12

  • +14 more secondary outcomes

Study Arms (1)

1

OTHER
Biological: Etanercept

Interventions

EtanerceptBIOLOGICAL

Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
  • Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
  • Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
  • Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.

    PMID: 15996057RESULT

  • Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.

    PMID: 12115173RESULT

  • 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.

    PMID: 20957659DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 26, 2006

Study Start

December 1, 1998

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

May 14, 2013

Results First Posted

December 8, 2010

Record last verified: 2013-05