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

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01649804

ML28146

2011-006125-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Participants who have prematurely withdrawn from the core study WA19926 for any reason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