Overview
Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Status:
Completed
Completed
Trial end date:
2014-03-04
2014-03-04
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AmgenTreatments:
Etanercept
Criteria
Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderateto 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.