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Completed

NCT Number: NCT00249041

Enbrel Liquid Immunogenicity Protocol

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50 mg etanercept

Drug

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Enbrel liquid

Drug

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Primary outcomes

  1. Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24

    Time frame: 24 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Immunex Corporation

Registry information

Official study title

Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Nov 7, 2005
Registry last updated
Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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