Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, RA, etanercept, Immunex, Amgen
Brief summary
The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.
Interventions
DRUGEtanercept Liquid
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate: * AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL; * Platelet count greater than or equal to 125,000/cm3; * White blood cell count (WBC) greater than or equal to 3500 cells/cm3; * Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study
Exclusion criteria
- Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes | — |
| Measurements from safety laboratory assessments. | — |
Outcome results
None listed