Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Enbrel liquid, antibodies
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.
Interventions
DRUG50 mg Etanercept
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
DRUGEnbrel liquid
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Sponsors
Immunex Corporation
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed