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

Rheumatoid Arthritis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099554
• Other study ID #: 20030236
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2004
• Last updated: November 12, 2009
• Start date: May 2004

Study information

• Verified date: November 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Bingham CO 3rd, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin. 2009 May;25(5):1131-42. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
Secondary	Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
Secondary	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
Secondary	Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
Secondary	Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
Secondary	Subject incidence rate of SAEs over 16 weeks

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling