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Study Complete
Sponsor ID
20040201

Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (etanercept) Auto-Injector versus Enbrel® Pre-Filled Syringes

Sponsor ID
20040201
Clinicaltrials.gov ID
NCT00094341
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
215
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

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
    Sep 2004 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Have established RA diagnosis as determined by ACR criteria - Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen - Subject must be able to self inject - Give written informed consent
    Exclusion Criteria:
    - Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) - Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding - Elective surgery is planned during study period - Subjects allergic to latex