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An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Juvenile Idiopathic Arthritis

Interventions: RoActemra/Actemra (tocilizumab)

Countries: Poland, Russia

This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment is 104 weeks.

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients who completed 104 weeks of study WA19977 with at least a JIA ACR30 clinical response to RoActemra/Actemra and no serious adverse event or adverse event
* Written informed consent obtained from patient if patient is 18 years of age and older, or if under the age of 18 years from parents or legal guardian

Exclusion Criteria:

* Patient did not benefit from RoActemra/Actemra therapy in study WA19977
* Treatment with any investigational drug since the last administration of study drug in the core study WA19977
* Patients developed any other autoimmune rheumatic disease other than the permitted JIA subsets
* Any significant medical or surgical condition that would jeopardize patient's safety
* Current serious uncontrolled concomitant disease or infection

Locations (11)

Bydgoszcz, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Sosnowiec, Poland
Moscow, Russia
Moscow, Russia
Moscow, Russia
Rostov-on-Don, Russia
Saint Petersburg, Russia
Samara, Russia