The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab delivered in current syringe; Adalimumab delivered in Physiolis syringe; Adalimumab delivered in current autoinjector; Adalimumab delivered in Physiolis autoinjector
Intervention description: Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously; Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously; Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously; Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid; Arthritis

Summary:

      This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and
      injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis
      pre-filled syringe and autoinjector used to administer adalimumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was judged to be in good health as determined by the investigator based upon
             the results of medical history, laboratory profile, physical examination, chest x-ray,
             and a 12-lead electrocardiogram performed during Screening.

          -  Subject had a negative purified protein derivative (PPD) test (or equivalent) and
             chest x-ray (posterior-anterior and lateral view) at Screening.

          -  Subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with
             adalimumab in accordance with the FDA-approved Humira prescribing information.

          -  Subject must have self-administered adalimumab subcutaneous (SC) 40 mg injections
             every other week (eow) without interruption for at least 3 months prior to Screening.

          -  For the Phase A portion of the study, the subject must be able and willing to self
             administer SC injections in the thigh or abdomen (administration by another person was
             not permissible).

        Exclusion Criteria:

          -  Subject has been treated with any investigational drug of chemical or biologic nature
             within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to
             the Visit 1, with the exception of adalimumab.

          -  Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days
             prior to the Visit 1 or oral anti-infectives within 14 days prior to Visit 1.

          -  Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).

          -  Known hypersensitivity to adalimumab or its excipients.

          -  Regular use of any SC medications, with the exception of adalimumab.