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Enbrel Liquid Immunogenicity Protocol

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: 50 mg Etanercept (Drug); Enbrel liquid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

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

Clinical Details

Official title: Open-Label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome: 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.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: October 2005
Ending date: March 2007
Last updated: April 10, 2008

Page last updated: June 20, 2008

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