A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Inclusion Criteria:

• Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
• No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
• Women of childbearing potential must agree to use highly reliable contraception during the treatment period

Exclusion Criteria:

• Pregnant or breastfeeding females
• Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
• Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
• Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
• Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
• Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
• Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
• Evidence of severe uncontrolled concomitant disease or disorder
• Known active infections or history of recurrent infections
• Active tuberculosis requiring treatment in the previous 3 years
• History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study