Back to resultsEnbrel Liquid Immunogenicity Protocol
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
50 mg Etanercept
Enbrel liquid
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Enbrel liquid, antibodies
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etanercept liquid
Arm Description
Outcomes
Primary Outcome Measures
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00249041
First Posted
November 3, 2005
Last Updated
July 29, 2010
Sponsor
Amgen
Collaborators
Immunex Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00249041
Brief Title
Enbrel Liquid Immunogenicity Protocol
Official Title
Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
Collaborators
Immunex Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Enbrel liquid, antibodies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etanercept liquid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
50 mg Etanercept
Intervention Description
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Intervention Type
Drug
Intervention Name(s)
Enbrel liquid
Intervention Description
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Primary Outcome Measure Information:
Title
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
12 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20156946
Citation
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.
Results Reference
result
Links:
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_916_ENBREL_20050145.pdf
Description
To access clinical trial results information click on this link
URL
http://www.enbrel.com/
Description
FDA-approved Drug Labeling
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Enbrel Liquid Immunogenicity Protocol
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