Enbrel Liquid Immunogenicity Protocol

Rheumatoid Arthritis Clinical Trial

Official title:

Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249041
• Other study ID #: 20050145
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2005
• Last updated: July 29, 2010
• Start date: October 2005
• Est. completion date: March 2007

Study information

• Verified date: July 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

Description:

The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: March 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Must be able to self-inject or have someone who can do so for them

• Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value

Exclusion Criteria:

• Any prior biologic therapy for inflammatory disease

• Any prior cyclophosphamide therapy

• Not using adequate contraception

• Pregnant or breast-feeding or any significant concurrent medical condition

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 50 mg Etanercept
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
• Enbrel liquid
50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

References & Publications (1)

Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24		24 weeks	Yes
Secondary	Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.		12 weeks and 24 weeks	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling