Enbrel Liquid Immunogenicity Protocol
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00249041
- Lead Sponsor
- Amgen
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etanercept liquid 50 mg Etanercept - Etanercept liquid Enbrel liquid -
- Primary Outcome Measures
Name Time Method Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 24 weeks
- Secondary Outcome Measures
Name Time Method 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. 12 weeks and 24 weeks