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.
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.
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.
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There are 37 Locations for this study
Huntsville Alabama, 35801, United States
Tuscaloosa Alabama, 35406, United States
Glendale Arizona, 85304, United States
Scottsdale Arizona, 85258, United States
Hot Springs Arkansas, 71913, United States
San Diego California, 92108, United States
San Ramon California, 94583, United States
Santa Maria California, 93454, United States
Tustin California, 92780, United States
Denver Colorado, 80230, United States
Dunedin Florida, 34698, United States
Tampa Florida, 33614, United States
Overland Park Kansas, 66215, United States
Louisville Kentucky, 40217, United States
Frederick Maryland, 21702, United States
Lansing Michigan, 48910, United States
Lincoln Nebraska, 68516, United States
Orchard Park New York, 14127, United States
Bismarck North Dakota, 58502, United States
Dayton Ohio, 45417, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Wyomissing Pennsylvania, 19610, United States
Charleston South Carolina, 29414, United States
Hixson Tennessee, 37343, United States
Austin Texas, 78731, United States
Dallas Texas, 75231, United States
Clarksburg West Virginia, 26301, United States
Victoria British Columbia, V8V 3, Canada
St. John's Newfoundland and Labrador, A1C 5, Canada
Barrie Ontario, L4M 7, Canada
Burlington Ontario, L7R 1, Canada
Courtice Ontario, L1E 3, Canada
Hamilton Ontario, L8N 1, Canada
Mississauga Ontario, L5M 2, Canada
Oakville Ontario, L6J 7, Canada
Peterborough Ontario, K9J 1, Canada
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