Overview

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

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Criteria
Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Patients 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

- Patients who have withdrawn prematurely from the WA19926 core study for any reason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