Active Rheumatoid Arthritis
Conditions
Keywords
Arthritis, Rheumatoid, Safety
Brief summary
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
Detailed description
Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.
Interventions
DRUGEtanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: \- Generally healthy of at least 18 years of age with active rheumatoid arthritis. Exclusion: \- A history or presence of clinically important medical disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA) | — |
Countries
Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, United Kingdom
Outcome results
None listed