Status:
COMPLETED
Enbrel Liquid Immunogenicity Protocol
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
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 subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00249041
Start Date
October 1 2005
End Date
March 1 2007
Last Update
July 30 2010
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