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

Date de début de l'étude : 9 décembre 2013

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contraception during the treatment period Exclusion Criteria: Pregnant or breastfeeding females Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason Treatment with any investigational agent or cell-depleting therapies since the last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