Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

Amgen

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099554

20030236

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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