Enbrel Liquid Immunogenicity Protocol
Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
1 other identifier
interventional
447
0 countries
N/A
Brief Summary
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Oct 2005
Shorter than P25 for phase_3 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJuly 30, 2010
July 1, 2010
1.2 years
November 3, 2005
July 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
24 weeks
Secondary Outcomes (1)
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
Study Arms (1)
Etanercept liquid
EXPERIMENTALInterventions
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Immunex Corporationcollaborator
Related 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.
PMID: 20156946RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 7, 2005
Study Start
October 1, 2005
Primary Completion
December 1, 2006
Study Completion
March 1, 2007
Last Updated
July 30, 2010
Record last verified: 2010-07