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Etanercept SFP in RA Patients

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

Secondary outcome:

Etanercept seroreactivity response to etanercept (manufactured using the SFP)

neutralizing antibodies to etanercept

Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: December 2006
Ending date: October 2007
Last updated: March 20, 2008

Page last updated: June 20, 2008

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