Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis

This is an interventional supportive care trial for Arthritis, Rheumatoid; Arthritis, Psoriatic Read More

Inclusion Criteria

• Subject has provided informed consent prior to initiation of any study specific activities/procedures.
• Male or female subject is 18 years of age or older at time of signing the informed consent form.
• Subject has a diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on investigator judgment.
• Subject is naïve to etanercept.
• Subject is able to self-inject etanercept.

Exclusion Criteria

• Subject is diagnosed with Felty's syndrome.
• Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions.
• Subject has a history of clinically significant skin allergies
• Subject has a history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes.
• Subject has any active infection for which anti-infectives were indicated within 4 weeks prior to screening.
• Subject has had a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to first dose of investigational product.
• Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
• Subject has known alcohol addiction or dependency.
• Subject has positive hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B virus deoxyribonucleic acid (DNA) test) or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. (Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).
• Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
• Subject has known history of active tuberculosis.
• Subject has used biologic disease modifying agent (DMARD) less than or equal to 3 months prior to screening.
• If subject is receiving continuous treatment with acetaminophen, non-steroidal anti-inflammatory drug or tramadol, hydrocodone, oxycodone, codeine, and/or propoxyphene and the dose is within 4 hours before study visit and dose is not stable for ≥ 2 weeks before first dose of investigational product
• For subjects not on continuous analgesics, subject has taken the following within 4 hours before screening: acetaminophen, non-steroidal anti-inflammatory drugs, hydrocodone, codeine, tramadol, propoxyphene, and/or oxycodone (unless in the form of OxyContin). For subjects not on continuous analgesics, subject has taken OxyContin within 24 hours before screening.
• Subject has received live vaccines less than or equal to 4 weeks prior to first dose of investigational product.
• Subject has laboratory abnormalities during screening.
• Estimated creatinine clearance less than 50 mL/min.
• Subject has any other laboratory abnormality, which, in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results.
• Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
• Other investigational procedures while participating in this study.
• Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment and/or within 4 weeks after the last dose of etanercept.
• Women of child-bearing potential with a positive pregnancy test.
• Women of child-bearing potential who are unwilling to practice true sexual abstinence or unwilling to use 1 of the following effective birth control methods during treatment and for an additional 4 weeks after the last dose of etanercept.