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Completed

NCT Number: NCT00413452

Etanercept SFP in RA Patients

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

50 mg once weekly

Primary outcomes

  1. Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 19, 2006
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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