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Study Complete
Sponsor ID
20050207

Study to Assess the Rate of Failure of an Enbrel® (etanercept) SureClick™ Auto-injector in Subjects with Rheumatoid Arthritis

Sponsor ID
20050207
Clinicaltrials.gov ID
NCT00346294
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
115
Additional Study Details

Protocol Summary

Primary Outcome Measures

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Timeframe: 22 Days

Secondary Outcome Measures

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.

Timeframe: 22 Days

To determine the rate of failed drug deliveries (as opposed to device failures).

Timeframe: 22 Days

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
    Jan 2006 - Mar 2006
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of rheumatoid arthritis - RA subjects - 18 years or older - Currently taking etanercept in pre-filled syringes for at least 4 weeks - Subjects must give written informed consent - Subjects must be able to read and write in English
    Exclusion Criteria:
    - Subject is not using adequate contraception - Subject is pregnant or breast feeding - Significant concurrent medical diseases