A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study

Roche

Status and phase

Completed

Phase 3

Conditions

Juvenile Idiopathic Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01667471

ML25756

2011-001097-25 (EudraCT Number)

Details and patient eligibility

About

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Enrollment

6 patients

Sex

All

Ages

9 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
Scheduled to receive first RoActemra/Actemra infusion in this study between 4 and 6 weeks after the last IV infusion in the core study
Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion criteria

Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
Any significant concomitant disease or medical or surgical condition
History of significant allergic or infusion reactions to prior biologic therapy
Known current active acute, subacute, chronic or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
Positive for latent tuberculosis (TB)
Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study
Inadequate hepatic, renal or bone marrow function