a long-term extension study of wa22762 to evaluate safety and efficacy of subcutaneous tocilizumab in participants with moderate to severe rheumatoid arthritis (ra).

Conditions: Rheumatoid Arthritis

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disease-modifying anti-rheumatic drugs (dmards) are allowed exclusion criteria: * participants who have prematurely withdrawn from the wa22762 lte study for any reason * previous treatment with any cell-depleting therapies, including investigational agents or approved therapies *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