A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Methotrexate; csDMARDs
Intervention description: Tocilizumab will be administered at a dose of 162 mg as SC injection once a week.; Methotrexate will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.; csDMARDs (at investigator's discretion) will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This two part, multi-center, open-label, single-arm study will evaluate the efficacy and
      safety of tocilizumab as a monotherapy or in combination with methotrexate or other
      conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with
      moderate to severe active rheumatoid arthritis who have an inadequate response or are
      intolerant to non-biologic csDMARDs and/or biologic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a diagnosis of active rheumatoid arthritis according to the revised
             (1987) ACR criteria or EULAR/ACR (2010) criteria and receiving outpatient treatment

          -  Oral corticosteroids (</= 10 mg/day prednisone or equivalent), nonsteroidal
             anti-inflammatory drugs (NSAIDs), and permitted csDMARDs are allowed at a stable dose
             for at least 4 weeks prior to Baseline

          -  At Screening either CRP >/=10 mg/L or ESR >/=20 mm/h and SJC >/=3 (based on 44 joints)

          -  Inadequate response (IR) to tumor necrosis factor, abatacept and/or non-biological
             DMARDs

        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 rheumatoid arthritis; Secondary Sjögren's
             syndrome with rheumatoid arthritis is permitted

          -  Functional Class IV as defined by the ACR Classification of Functional Status in
             Rheumatoid Arthritis

          -  Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or
             rheumatoid arthritis before the age of 16

          -  Prior history of or current inflammatory joint disease other than rheumatoid arthritis

          -  Exposure to tocilizumab at any time prior to Baseline

          -  Treatment with any investigational agent within 4 weeks (or five half-lives of the
             investigational drug, whichever was longer) of Screening

          -  Previous treatment with any cell-depleting therapies, including investigational agents
             or approved therapies or any alkylating agents such as chlorambucil, or with total
             lymphoid irradiation

          -  Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline

          -  Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline

          -  Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline

          -  History of severe allergic or anaphylactic reactions to human, humanized, or murine
             monoclonal antibodies

          -  Serious uncontrolled concomitant disease or other significant condition

          -  History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic
             ulcerative lower gastrointestinal disease

          -  Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other
             infections

          -  Any infection requiring hospitalization or treatment with 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 C

          -  Primary or secondary immunodeficiency disorder

          -  Active cancer, or cancer diagnosed within the previous 10 years (except basal and
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has
             been excised or cured), or breast cancer diagnosed within the previous 20 years

          -  History of alcohol, drug, or chemical abuse within 1 year prior to Screening

          -  Neuropathies or other conditions that might interfere with pain evaluation