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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727986
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: tocilizumab [RoActemra/Actemra] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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)
Study Start Date : March 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727986

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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
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01727986    
Other Study ID Numbers: ML28413
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases