A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: Participants will receive TCZ 162 milligrams (mg) SC injection once a week.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label, single arm, interventional, long-term extension (LTE) study
      will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French
      participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE
      study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed
      the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having
      improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2
      points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of
      subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever
      occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative pregnancy test at screening and baseline

          -  Participants who have completed the 97-week WA22762 LTE study on SC or intravenous
             (IV) TCZ and who experienced, at any time during WA22762, clinically significant
             improvement in DAS28 (>1.2 points), and based on the investigator's judgment may
             continue to benefit from TCZ treatment in this study investigating the SC formulation

          -  No current or recent adverse events or laboratory findings preventing the use of the
             study drug dose of TCZ 162 mg SC at baseline visit

          -  Receiving treatment on an outpatient basis

          -  Females of childbearing potential and males with female partners of childbearing
             potential must agree to use reliable means of contraception during the study and for
             at least 3 months following the last dose of study drug

          -  Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the
             recommended dose are permitted if on stable dose regimen for greater than and equal to
             (>/=) 4 weeks prior to baseline

          -  Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed

        Exclusion Criteria:

          -  Participants who have prematurely withdrawn from the WA22762 LTE study for any reason

          -  Previous treatment with any cell-depleting therapies, including investigational agents
             or approved therapies

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
             or a T-cell co stimulation modulator since the last administration of study drug in
             the WA22762 LTE study

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in the WA22762 LTE study

          -  Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other
             than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted

          -  Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other
             than RA

          -  Uncontrolled disease states, such as asthma or inflammatory bowel disease, where
             flares are commonly treated with oral or parenteral corticosteroids

          -  Evidence of serious uncontrolled concomitant disease

          -  Known active current or history of recurrent infection

          -  Primary or secondary immunodeficiency (history of or currently active)

          -  Body weight >150 kilograms (kg)

          -  Pregnant or lactating women

          -  Inadequate hematologic, renal or liver function

          -  History of alcohol, drug or chemical abuse within 1 year prior to screening