Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Detailed description
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
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
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Presence of \>6 swollen joints and \>6 tender joints * Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD) * Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit
Exclusion criteria
* Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors * Received investigational drugs within 6 months of the baseline visit * Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness. | — |
Countries
Japan
Outcome results
None listed