A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab
Intervention description: 162 milligram (mg) administered subcutaneously once weekly for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multi-center, open-label single-arm study to evaluate the efficacy and safety of
      tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis.
      Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic
      drugs (DMARDs) was permitted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >/= 18 years of age

          -  Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) American
             College of Rheumatology (ACR) criteria or European League Against Rheumatism
             (EULAR)/ACR (2010) criteria

          -  Previously treated with the following: three non-biologic DMARDs, and not treated with
             any biologic agent OR one biologic agent (alone or in combination with non-biologic
             DMARDs), and discontinued that agent for a reason

          -  Oral corticosteroids (</= 10 mg/day prednisone or equivalent), non-steroidal
             anti-inflammatory drug (NSAIDs) and non-biologic DMARDs are permitted if on a stable
             dose regimen for >/= 4 weeks prior to Baseline

          -  Use of effective contraception throughout the study as defined by protocol; female
             patients of childbearing potential must not be pregnant

        Exclusion Criteria:

          -  Presence of serious, uncontrolled, clinically significant medical conditions

          -  History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic
             ulcerative lower gastrointestinal (GI) disease that might predispose to perforation

          -  Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other
             infections

          -  Any infection requiring hospitalization or treatment with intravenous (IV) antibiotics
             within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening

          -  Clinically significant findings on lab tests and/or hepatitis B or C, or human
             immunodeficiency virus (HIV) screenings

          -  Active tuberculosis (TB) requiring treatments within the previous 3 years

          -  Evidence of active malignant disease, malignancies diagnosed within the previous 10
             years, 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

          -  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, including systemic lupus erythematosus,
             mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic
             involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's
             syndrome). Secondary Sjögren's syndrome with RA is permitted

          -  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 current inflammatory joint disease other than RA

          -  Exposure to tocilizumab (either IV or subcutaneous administration) at any time prior
             to Baseline

          -  Treatment with any investigational agent within 4 weeks (or five half-lives of the
             investigational drug, whichever is longer) of Screening

          -  Previous treatment with any cell-depleting therapies, including investigational agents
             approved therapies, with alkylating agents such as chlorambucil, or with total
             lymphoid irradiation

          -  Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline

          -  Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline