Etanercept SFP in RA Patients

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413452
• Other study ID #: 20060104
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2006
• Last updated: February 12, 2009
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
50 mg once weekly

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)		24 weeks	Yes
Secondary	Etanercept seroreactivity response to etanercept (manufactured using the SFP)		week 12	Yes
Secondary	neutralizing antibodies to etanercept		week 12 and 24	Yes
Secondary	Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments		week 24	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling