Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis
Condition: Arthritis, Rheumatoid; Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic
Intervention: Commercial Formulation Etanercept; New Formulation Etanercept
Intervention description: Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.; Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective was to assess the injection site pain associated with the new
      formulation of etanercept compared with commercial etanercept in adults with rheumatoid
      arthritis (RA) or psoriatic arthritis (PsA) as measured by a visual analog scale (VAS).
    

Eligibility criteria:

        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.