TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab
Intervention description: Fixed dose of 162 mg subcutaneously weekly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm study will evaluate the efficacy, safety and tolerability of
      subcutaneously administered tocilizumab in monotherapy and/or in combination with
      methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in
      participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants
      will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants
      who complete the core study achieving at least a moderate European League Against Rheumatism
      (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks
      at the most.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Active moderate to severe rheumatoid arthritis according to the revised (1987)
             American College of Rheumatology (ACR) criteria or EULAR/ACR (2010) criteria

          -  Inadequate response or intolerant to previous therapy with two or more non-biologic
             disease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate,
             administered in an optimal way during at least 3 months; eligible participants may
             also be inadequate responders to a maximum of one biologic DMARD

          -  Oral corticosteroids (</= 10 milligram per day (mg/day) prednisolone or equivalent)
             and non-steroidal anti-inflammatory drugs (NSAIDs; up to the recommended dose) are
             permitted if on stable dose regimen for >/= 4 weeks prior to baseline

          -  Permitted DMARDs are allowed if at stable dose for at least 4 weeks prior to baseline

          -  Receiving treatment on an outpatient basis, not including tocilizumab

          -  Females of childbearing potential and males with female partners of childbearing
             potential must agree to use reliable means of contraception as defined by protocol

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following baseline or during long term extension (LTE)
             period

          -  Rheumatic autoimmune disease other than rheumatoid arthritis

          -  Functional Class IV as defined by the ACR Classification of Functional Status in
             Rheumatoid Arthritis

          -  Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of
             16

          -  Prior history of or current inflammatory joint disease other than RA

          -  Exposure to tocilizumab (intravenous or subcutaneous) at any time prior to baseline

          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of the
             investigational drug, whichever is longer) of screening

          -  Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

          -  History of severe allergic or anaphylactic reactions to human, humanized or murine
             monoclonal antibodies

          -  Evidence of serious concomitant disease or disorder

          -  Known active current or history of recurrent infection

          -  Any major episode of infection requiring hospitalization or treatment with IV
             antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of
             screening

          -  Active Tuberculosis (TB) requiring treatment within the previous 3 years

          -  Positive for hepatitis B or hepatitis C

          -  Primary or secondary immunodeficiency (history of or currently active)

          -  Pregnant or lactating women

          -  Neuropathies or other conditions that might interfere with pain evaluation

          -  Inadequate hematologic, renal or liver function