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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 8, 2012
Last updated: May 4, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Juvenile Idiopathic Arthritis Drug: tocilizumab [RoActemra/Actemra] Phase 3

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Long-term safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

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

Enrollment: 11
Study Start Date: March 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks


Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01727986

Rio de janeiro, RJ, Brazil, 20551030
Rio de Janeiro, RJ, Brazil, 21941-912
Porto Alegre, RS, Brazil, 90035-003
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01727986     History of Changes
Other Study ID Numbers: ML28413
Study First Received: November 8, 2012
Last Updated: May 4, 2016

Additional relevant MeSH terms:
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 21, 2017