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

• Status: Completed
• Trial end date: 2016-05-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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• Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason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