Status:
COMPLETED
Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept. Participants must be naï...
Eligibility Criteria
Inclusion
- Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -
Exclusion
- Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept. - Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
- Other criteria may apply.
Key Trial Info
Start Date :
June 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2014
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01875991
Start Date
June 5 2013
End Date
March 4 2014
Last Update
September 4 2018
Active Locations (37)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Tuscaloosa, Alabama, United States, 35406
3
Research Site
Glendale, Arizona, United States, 85304
4
Research Site
Scottsdale, Arizona, United States, 85258