Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.
Interventions
DRUGEtanercept
DRUGMethotrexate
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who completed the previous double-blind,randomized study. * Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.
Exclusion criteria
* Dose of prednisone\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. * Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. | — |
Outcome results
None listed