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

Extension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: tocilizumab [RoActemra/Actemra]

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-912
    • Rio de janeiro, RJ, Brazil, 20551030
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
  • SP
    • Sao Paulo, SP, Brazil, 05403-000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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
• Currently active primary or secondary immunodeficiency
• Current abuse of alcohol, drugs or chemical abuse
• Known and currently active acute, subacute, chronic infections 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RoActemra/Actemra	Drug: tocilizumab [RoActemra/Actemra]; 8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long-term safety: Incidence of adverse events	approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)	approximately 3 years
Proportion of patients achieving inactive disease/clinical remission	approximately 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (ESTIMATE): November 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: ML28413