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



Status:Completed
Conditions:Arthritis, Psoriasis, Rheumatoid Arthritis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:June 5, 2013
End Date:March 4, 2014

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An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept

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.

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.

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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Victoria,
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