A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; DMARDs
Intervention description: Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week.; Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab
      (RoActemra), administered as monotherapy or in combination with methotrexate and/or other
      DMARDs, in participants with moderate to severe active RA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR
             (2010) criteria

          -  Moderate to severe RA (CDAI at least [>/=] 10 and DAS28 >/=3.2) at screening

          -  Tumor necrosis factor inhibitors-inadequate responder (TNF-IR),
             methotrexate-inadequate responder (MTX-IR), and/or DMARDs-inadequate responder
             (DMARDs-IR)

          -  Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisone or
             equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the maximum
             recommended dose) are permitted if on a stable dose regimen for >/=4 weeks prior to
             baseline

          -  Permitted non-biologic DMARDs are allowed if at a stable dose for >/=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 a reliable means of contraception for at least 3 months
             following the last dose of tocilizumab

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 12 months following baseline

          -  Rheumatic autoimmune disease other than RA; secondary Sjögren's syndrome with RA is
             permitted

          -  Functional Class IV as defined by the ACR Classification of Functional Status in RA

          -  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 (either intravenous [IV] or SC) 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

          -  Previous treatment with any cell-depleting therapies

          -  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 uncontrolled concomitant cardiovascular, nervous system,
             pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or
             gastrointestinal disease

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
             or other infections

          -  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 surface antigen or hepatitis C antibody

          -  Primary or secondary immunodeficiency (history of or currently active)

          -  Evidence of active malignant disease, malignancies diagnosed within the previous 10
             years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ
             of the cervix uteri that has been excised and cured), or breast cancer diagnosed
             within the previous 20 years

          -  Pregnant or breast feeding women

          -  Neuropathies or other conditions that might interfere with pain evaluation