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

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01655381

2011-005516-29 (EudraCT Number)

ML28174

Details and patient eligibility

About

This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult participants, >/= 18 years of age
Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment
No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit
Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment

Exclusion criteria

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Participants who have withdrawn prematurely from the WA19926 core study for any reason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