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
Completed
Trial end date:
2015-06-01
2015-06-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
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- Patients who have withdrawn prematurely from the WA19926 core study for any reason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