Status:
COMPLETED
Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 subcut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00099554
Start Date
May 1 2004
Last Update
November 13 2009
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