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

• ClinicalTrials.gov Identifier: NCT00099554
• Recruitment Status: Completed
• First Posted: December 17, 2004
• Last Update Posted: November 13, 2009
• Sponsor: Amgen
• Information provided by: Amgen

Tracking Information

• First Submitted Date: December 16, 2004
• First Posted Date: December 17, 2004
• Last Update Posted Date: November 13, 2009
• Study Start Date: May 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 9, 2005): Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 9, 2005)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Intervention: Drug: Etanercept
• Study Arms: Not Provided
• Publications *: 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: 10.1185/03007990902841010.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: August 30, 2007): 200
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00099554
• Other Study ID Numbers: 20030236
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Global Development Leader, Amgen Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: November 2009