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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00099554
Date of registration: 16/12/2004
Prospective Registration: Yes
Primary sponsor: Amgen
Public title: Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
Scientific title: A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
Date of first enrolment: May 2004
Target sample size: 200
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Canada United States
Name:     MD
Affiliation:  Amgen
Key inclusion & exclusion criteria

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

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Etanercept
Primary Outcome(s)
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
Secondary Outcome(s)
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
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
Subject incidence rate of SAEs over 16 weeks
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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