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
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