An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: 162 milligrams (mg) tocilizumab was 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: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in
      patients with active moderate to severe rheumatoid arthritis. Participants will receive a
      subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment
      is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients at least 18 years of age

          -  Patients with a diagnosis of active moderate to severe rheumatoid arthritis (RA)

          -  Oral corticosteroids and nonsteroidal anti-inflammatory are permitted if on a stable
             dose regimen for >/= 4 weeks prior baseline

          -  Permitted non-biologic disease-modifying anti-rheumatic drugs (DMARDs) used alone or
             in combination are allowed if at a 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 may participate in this study only if using a reliable means of
             contraception for at least 5 months following the last dose tocilizumab

          -  Previous or current treatment with methotrexate with an inadequate response to
             methotrexate, intolerance to methotrexate or treatment with methotrexate was
             considered as inappropriate

          -  Evidence of one or more erosions in hands or feet assessed by X-ray attributable to RA
             or magnetic resonance imaging (MRI) of wrist of metacarpophalangeal (MCP) joints of
             dominant hand

        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

          -  Functional Class IV as defined by the American College of Rheumatology (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 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

          -  Treatment with intravenous (IV) gamma globulin, plasmapheresis within 6 months of
             baseline

          -  Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to baseline

          -  Any previous treatment with alkylating agents such as chlorambucil, or with total
             lymphoid irradiation

          -  Treatment with 2 or more anti-tumor necrosis factor (TNF) agents or any other biologic
             agent at any time prior to screening

          -  Evidence of serious uncontrolled concomitant disease (e.g., cardiovascular, nervous
             system, pulmonary)

          -  History of diverticulitis, diverticulosis requiring antibiotic treatment, or chromic
             ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative
             colitis, or other symptomatic lower genitourinary (GU) conditions that might
             predispose to perforation

          -  Known active current or history of recurrent infections