Study Complete
Sponsor ID
20090176

Preference Between Two Autoinjectors in Patients with Rheumatoid Arthritis and Plaque Psoriasis Treated with Etanercept

Sponsor ID
20090176
Clinicaltrials.gov ID
NCT01875991
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
217
Additional Study Details

Protocol Summary

Primary Outcome Measures

Preference for autoinjector A versus autoinjector B assessed by the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at week 8.

Timeframe: At week 8

Secondary Outcome Measures

Using the Subject’s Perception of Self-injecting Questionnaire the following secondary endpoint will be evaluated at baseline and at week 4 prior to training with the autoinjector

Timeframe: At baseline and Week 4

Using the Subject’s Experience with the Autoinjector Questionnaire, the following secondary endpoints will be evaluated after the completion of each 4-week treatment period

Timeframe: At week 4 and week 8

Certainty of completing the injection with the autoinjector

Timeframe: At week 4 and week 8

Convenience

Timeframe: At week 4 and week 8

Discomfort

Timeframe: At week 4 and week 8

Satisfaction

Timeframe: at week 4 and week 8

Pain associated with use of the autoinjector

Timeframe: At week 4 and week 8

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Austin, TX, United States, 78731
Status
Recruiting
Location
Research Site
Barrie, ON, Canada, L4M 7G1
Status
Recruiting
Location
Research Site
Bismarck, ND, United States, 58502
Status
Recruiting
Location
Research Site
Charleston, SC, United States, 29414
Status
Recruiting
Location
Research Site
Clarksburg, WV, United States, 26301
Status
Recruiting
Location
Research Site
Courtice, ON, Canada, L1E 3C3
Status
Recruiting
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