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

NCT01665430

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: Tocilizumab

Countries: Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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* Participants who have prematurely withdrawn from the WA19926 study for any reason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

Locations (4)

Bytom, Poland
Elblag, Poland
Poznan, Poland
Warsaw, Poland