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Study Complete
Sponsor ID
20060104

Etanercept SFP in RA patients

Sponsor ID
20060104
Clinicaltrials.gov ID
NCT00413452
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
224
Additional Study Details

Protocol Summary

Primary Outcome Measures

Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

Timeframe: 24 weeks

Secondary Outcome Measures

Etanercept seroreactivity response to etanercept (manufactured using the SFP)

Timeframe: week 12

neutralizing antibodies to etanercept

Timeframe: week 12 and 24

Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments

Timeframe: week 24

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Dec 2006 - Aug 2007
    Inclusion and Exclusion Criteria
    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