Psoriasis Clinical Trial

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

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.

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Full 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 naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject. The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B). At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

217

Study ID:

NCT01875991

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 37 Locations for this study

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Research Site
Huntsville Alabama, 35801, United States
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Tuscaloosa Alabama, 35406, United States
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Glendale Arizona, 85304, United States
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Scottsdale Arizona, 85258, United States
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Hot Springs Arkansas, 71913, United States
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San Diego California, 92108, United States
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San Ramon California, 94583, United States
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Santa Maria California, 93454, United States
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Tustin California, 92780, United States
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Denver Colorado, 80230, United States
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Dunedin Florida, 34698, United States
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Tampa Florida, 33614, United States
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Overland Park Kansas, 66215, United States
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Louisville Kentucky, 40217, United States
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Frederick Maryland, 21702, United States
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Lansing Michigan, 48910, United States
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Lincoln Nebraska, 68516, United States
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Orchard Park New York, 14127, United States
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Bismarck North Dakota, 58502, United States
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Dayton Ohio, 45417, United States
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Oklahoma City Oklahoma, 73103, United States
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Duncansville Pennsylvania, 16635, United States
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Wyomissing Pennsylvania, 19610, United States
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Charleston South Carolina, 29414, United States
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Hixson Tennessee, 37343, United States
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Austin Texas, 78731, United States
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Dallas Texas, 75231, United States
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Clarksburg West Virginia, 26301, United States
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Victoria British Columbia, V8V 3, Canada
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St. John's Newfoundland and Labrador, A1C 5, Canada
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Barrie Ontario, L4M 7, Canada
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Burlington Ontario, L7R 1, Canada
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Courtice Ontario, L1E 3, Canada
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Hamilton Ontario, L8N 1, Canada
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Mississauga Ontario, L5M 2, Canada
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Oakville Ontario, L6J 7, Canada
Research Site
Peterborough Ontario, K9J 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

217

Study ID:

NCT01875991

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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