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Etanercept SFP in RA Patients

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ClinicalTrials.gov Identifier: NCT00413452
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : February 13, 2009
Information provided by:

Study Description
Brief Summary:
Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Etanercept Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.
Study Start Date : December 2006
Primary Completion Date : August 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 50 mg
50 mg once weekly
Drug: Etanercept
50 mg once weekly

Outcome Measures

Primary Outcome Measures :
  1. Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Etanercept seroreactivity response to etanercept (manufactured using the SFP) [ Time Frame: week 12 ]
  2. neutralizing antibodies to etanercept [ Time Frame: week 12 and 24 ]
  3. Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments [ Time Frame: week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
  • Naïve to etanercept therapy
  • Able to self-inject investigational product or have a designee who can do so
  • Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
  • Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
  • Receipt of MTX witin 30 days of 1st dose of investigational product
  • Receipt of an other investigational drug within 30 days of 1st dose
  • Receipt of TNF inhibitor therapy within 90 days of 1st dose
  • Receipt of cyclophosphamide within 6 mo of 1st dose
  • Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
  • Current use of insulin
  • gnificant concurrent medical condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413452

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00413452     History of Changes
Other Study ID Numbers: 20060104
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Amgen:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors