A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult participants, >/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment

• No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline

• Receiving treatment on an outpatient basis

Exclusion Criteria:

• Females who are pregnant

• Participants who have prematurely withdrawn from the core study WA19926 for any reason

• Treatment with any investigational drug since the last administration of the study drug in the core study WA19926

• Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926

• Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926

• Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis

• Abnormal laboratory values