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Etanercept SFP in RA Patients

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
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


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: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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


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


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

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

FDA-approved Drug Labeling

AmgenTrials clinical trials website

Starting date: December 2006
Last updated: February 12, 2009

Page last updated: August 20, 2015

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