Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a good or moderate DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.
Interventions
DRUGEtanercept
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
* Adults with RA (ACR criteria) for greater than or equal to 6 months * Infliximab treatment for at least 18 weeks * Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency) * Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints * Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening * Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening * Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening * Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening
Exclusion criteria
* ACR functional class IV - Prior treatment with etanercept * Receipt of any investigational drug/biologic within 28 days of study drug initiation * Active infection or predisposition to infection * Elective surgery planned during study period * Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening * Contraindications to etanercept as defined in the package insert * Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a good or moderate DAS28 response (as defined by EULAR28 criteria) at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16. | — |
| Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16 | — |
| Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16. | — |
| Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16 | — |
| Subject incidence rate of SAEs over 16 weeks | — |
Outcome results
None listed