Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
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ClinicalTrials.gov Identifier: NCT00099554 |
Recruitment Status :
Completed
First Posted : December 17, 2004
Last Update Posted : November 13, 2009
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Sponsor:
Amgen
Information provided by:
Amgen
Tracking Information | ||||
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First Submitted Date ICMJE | December 16, 2004 | |||
First Posted Date ICMJE | December 17, 2004 | |||
Last Update Posted Date | November 13, 2009 | |||
Study Start Date ICMJE | May 2004 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16. | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab) | |||
Official Title ICMJE | 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Rheumatoid Arthritis | |||
Intervention ICMJE | Drug: Etanercept | |||
Study Arms ICMJE | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
200 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Canada, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00099554 | |||
Other Study ID Numbers ICMJE | 20030236 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Global Development Leader, Amgen Inc. | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Amgen | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | November 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |