Rheumatoid Arthritis
Conditions
Brief summary
To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.
Interventions
DRUGEtanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide). * Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy). * Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.
Exclusion criteria
* Uncooperative patients with a history of poor compliance. * Known hypersensitivity to etanercept or any of its components. * Known significant concurrent medical disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate. | — |
Outcome results
None listed