A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab
Intervention description: Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: On label Humira users; Rheumatoid Arthritis; Pain

Summary:

      This study will compare injection site pain levels between current Humira® formulation versus
      a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either
      currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological
      naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The
      study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and
      Germany (2 sites).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject age 18 years or older, who requires Humira 40 mg SC every other
             week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance
             with the local Humira label.

          -  Subject must be a current, on-label user of Humira who rates his/her average Humira
             injection site related pain as at least 3 cm on a pain Visual Analogue Scale and has
             had at least 6 consecutive doses of Humira prior to Screening, or a biologic naïve
             subject who requires initiation of on-label treatment with Humira.

          -  Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACR
             classification criteria or the ACR/EULAR 2010 criteria,

          -  Female subjects are either not of childbearing potential, defined as postmenopausal
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy and/or hysterectomy), or are practicing at least one method of birth
             control throughout the study and for at least 70 days after the last dose of study
             drug.

          -  All female subjects of childbearing potential must have a negative test for pregnancy
             on a serum sample at Screening and prior to study drug dosing on a urine sample
             obtained at Visit 1.

        Exclusion Criteria:

          -  Subject has been treated with any investigational drug of a chemical or biologic
             nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug
             prior to Visit 1.

          -  Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30
             days prior to 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.

          -  History of demyelinating disease (including myelitis) or neurologic symptoms
             suggestive of demyelinating disease.