Etanercept SFP in RA Patients

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00413452
First received: December 15, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Etanercept seroreactivity response to etanercept (manufactured using the SFP) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • neutralizing antibodies to etanercept [ Time Frame: week 12 and 24 ] [ Designated as safety issue: Yes ]
  • Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg
50 mg once weekly
Drug: Etanercept
50 mg once weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413452

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00413452     History of Changes
Other Study ID Numbers: 20060104
Study First Received: December 15, 2006
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Rheumatoid Arthritis
Etanercept
Enbrel
Amgen

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

ClinicalTrials.gov processed this record on April 22, 2014