A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis

Roche

Status and phase

Terminated

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01665430

2012-000172-42 (EudraCT Number)

ML28175

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who complete WA19926 core study (visit at Week 104 and two follow-up telephone visits) 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 tocilizumab 8 mg/kg at baseline visit
Receiving treatment on an outpatient basis
Females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period

Exclusion criteria

Pregnant women
Participants who have prematurely withdrawn from the WA19926 study for any reason
Treatment with any investigational agent or cell depleting therapies since last administration of study drug in the WA19926 core study
Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL)1 agent, or a T-cell co-stimulation modulator since the last administration of the study drug in the WA19926 core study
Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
Diagnosis since visit at Week 104 of the core WA19926 study of rheumatic autoimmune disease other than rheumatoid arthritis
Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint disease other than rheumatoid arthritis
Evidence of serious uncontrolled concomitant disease or disorder
Known active or history of recurrent infection
Current liver disease as determined by Investigator