A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Methotrexate; Non-Biologic DMARDs
Intervention description: Tocilizumab 162 mg will be administered subcutaneously QW.; Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.; Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and
      tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with
      methotrexate or other non-biologic DMARDs in participants with active RA who are naive to
      tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly
      (QW) for 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria

          -  Moderate to severe RA with a DAS28-ESR score >3.2 points

          -  Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or
             where MTX or other non-biologic DMARDs are inappropriate

          -  Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or
             equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable
             dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline

          -  Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to
             baseline

          -  Receiving treatment on an outpatient basis, not including tocilizumab

          -  Agreement to use reliable means of contraception as defined by protocol, among females
             of childbearing potential and males with female partners of childbearing potential

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following baseline

          -  Rheumatic autoimmune disease other than RA

          -  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 or any other biologic DMARDs 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

          -  Intra-articular 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 intravenous
             (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of
             screening

          -  Active tuberculosis requiring treatment within the previous 3 years

          -  Positive for hepatitis B or hepatitis C

          -  History of or current active primary or secondary immunodeficiency

          -  Pregnant or lactating women

          -  Neuropathies or other conditions that might interfere with pain evaluation

          -  Inadequate hematologic, renal, or liver function