Study Complete
Sponsor ID
20050145

Enbrel Liquid Immunogenicity protocol

Sponsor ID
20050145
Clinicaltrials.gov ID
NCT00249041
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
447
Additional Study Details

Protocol Summary

Primary Outcome Measures

Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24

Timeframe: 24 weeks

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.

Timeframe: 12 weeks and 24 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.