An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis

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 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Inclusion Criteria:

• Adult participants, >/= 18 years of age
• Participants who complete their last WA19926 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 the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
• Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period

Exclusion Criteria:

• Pregnant females
• Participants who have withdrawn prematurely from the WA19926 core study for any reason
• Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
• 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
• Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
• Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
• Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
• 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 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 study