Enbrel Liquid Immunogenicity Protocol

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00249041
First received: November 3, 2005
Last updated: July 29, 2010
Last verified: July 2010

November 3, 2005
July 29, 2010
October 2005
December 2006   (final data collection date for primary outcome measure)
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
Complete list of historical versions of study NCT00249041 on ClinicalTrials.gov Archive Site
Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks. [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.
Not Provided
Not Provided
 
Enbrel Liquid Immunogenicity Protocol
Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: 50 mg Etanercept
    50 mg Etanercept liquid injected SC once weekly using prefilled syringes
  • Drug: Enbrel liquid
    50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Experimental: Etanercept liquid
Interventions:
  • Drug: 50 mg Etanercept
  • Drug: Enbrel liquid
Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
March 2007
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Must be able to self-inject or have someone who can do so for them
  • Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value

Exclusion Criteria:

  • Any prior biologic therapy for inflammatory disease
  • Any prior cyclophosphamide therapy
  • Not using adequate contraception
  • Pregnant or breast-feeding or any significant concurrent medical condition
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00249041
20050145
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Immunex Corporation
Study Director: MD Amgen
Amgen
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP