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CompletedNCT02165345Updated Feb 23, 2022

Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis

A Phase 1 interventional study of Tocilizumab in Juvenile Idiopathic Arthritis, sponsored by Hoffmann-La Roche. Completed at 31 sites in 12 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-02-23.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
2 Years to 18 Years
Sex
All
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Study summary

This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.

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Conditions studied

  • Juvenile Idiopathic Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 82 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completion of either of the JIGSAW studies, study WA28117 (for participants with pJIA) or study WA28118 (for participants with sJIA)
  • Adequate disease control with the use of SC tocilizumab(TCZ)(comparable to the use of IV TCZ, if received prior to enrollment in the JIGSAW study), per clinical judgment of the investigator
  • For participants of reproductive potential: agreement to remain abstinent or use of effective contraception as defined by the study protocol

Exclusion criteria

Exclusion Criteria:

  • Prior discontinuation of SC tocilizumab because of inadequate clinical response during participation in a JIGSAW study
  • Poorly controlled disease (in opinion of treating physician) despite treatment with SC tocilizumab in the JIGSAW study
  • Prior discontinuation of intravenous tocilizumab because of inadequate clinical response or safety events (including hypersensitivity)
  • Therapy with biologic agents (except tocilizumab) in the period between completion of the JIGSAW study and screening for the current study
  • Concurrent treatment with disease-modifying anti-rheumatic drugs (DMARDs) (including methotrexate), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids is permitted at the discretion of the investigator
  • Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide
  • Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
  • History of alcohol, drug, or chemical abuse within 6 months prior to screening
  • History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening
  • Known human immunodeficiency virus infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
  • Clinical signs or symptoms of acute or chronic viral hepatitis or chronic autoimmune hepatitis arising since enrollment in the JIGSAW study
  • History of concurrent serious gastrointestinal disorders, such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
  • History of or current cancer or lymphoma
  • Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin (HbA1c), defined with the use of age-specific standards
  • Any abnormal laboratory values, an elevation of hepatic transaminases ([aspartate aminotransferase [AST] or alanine aminotransferase [ALT]), lowering of neutrophil count, or thrombocytopenia attributed to tocilizumab use by investigator at screening, the participant may be enrolled; however, the initial tocilizumab dose may be delayed to adhere to the protocol risk mitigation strategy or per the investigator's clinical judgment
  • Prior stem cell transplant at any time
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Tocilizumab

    Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.

    Drug: Tocilizumab

Interventions

  • DrugTocilizumab

    162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (\<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (\>=) 30 kg: every 2 weeks; sJIA participants \<30 kg: every 2 weeks; sJIA participants \>/= 30 kg: once weekly

    Also known as: RoActemra, Actemra

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What researchers measure

Primary outcomes

  1. Juvenile Arthritis Disease Activity Score (JADAS-71)

    Time frame: Baseline up to 3 years

  2. Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest

    Time frame: Baseline up to 5 years

Secondary outcomes

  1. Childhood Health Assessment Questionnaire (CHAQ) Score

    Time frame: Baseline up to 3 years

  2. Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission

    Time frame: Baseline up to 3 years

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Study locations

31 sites
  • Arkansas Children's Hospital Research Institute
    Little Rock, Arkansas 72202, United States
  • University of Chicago Hospital
    Chicago, Illinois 60637, United States
  • Hackensack University Medical Center; Pediatric Rheumatology
    Hackensack, New Jersey 07601, United States
  • Duke University
    Durham, North Carolina 27705, United States
  • Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
    Cincinnati, Ohio 45229-3039, United States
  • Cleveland Clinic Fndn
    Cleveland, Ohio 44195, United States
  • Healthcare Research Consultants
    Tulsa, Oklahoma 74135, United States
  • University of Utah; Immunology/Rheumatology/Allergy
    Salt Lake City, Utah 84109, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • Hospital Gral de Niños Pedro Elizalde
    Buenos Aires, C1270AAN, Argentina
  • Hospital de Ninos de la Santisima Trinidad; Hematología
    Cordoba, X5000XAF, Argentina
  • Westmead Hospital; Paediatric Rheumatology
    Westmead, New South Wales 2145, Australia
  • Royal Children'S Hospital; Paediatric Rheumatology
    Parkville, Victoria 3052, Australia
  • Universidade Federal de Sao Paulo - UNIFES
    Sao Paulo, SP 04026-000, Brazil
  • Hospital das Clinicas - FMUSP
    Sao Paulo, SP 05403-900, Brazil
  • Alberta Children'S Hospital
    Calgary, Alberta T3B 6A8, Canada
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
  • CH de Bicêtre; Pediatrie Generale
    Le Kremlin Bicêtre, 94275, France
  • Charité Campus; Virchow Klinikum Berlin
    Berlin, 13353, Germany
  • Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie
    Freiburg, 79106, Germany
  • Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie
    Sankt Augustin, 53757, Germany
  • Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina
    Roma, Lazio 00165, Italy
  • Hospital Infantil de México "Federico Gomez"; Rheumatology
    Mexico, 06720, Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
    Monterrey, 64460, Mexico
  • SI Sceintific children health center RAMS
    Moscow, 119991, Russian Federation
  • Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica
    Esplugas DE Llobregat, Barcelona 08950, Spain
  • Hospital Ramon y Cajal ; Servicio de Reumatologia
    Madrid, 28034, Spain
  • Hospital de La Paz; Unidad de Reumatologia Pediatrica
    Madrid, 28046, Spain
  • Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
    Valencia, 46026, Spain
  • Bristol Royal Hospital for Children; Rheumatology Department
    Bristol, BS2 8BJ, United Kingdom
  • Alder Hey Children's NHS Foundation Trust
    Liverpool, L12 2AP, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02165345
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 17, 2014
Start date
Jul 16, 2014
Primary completion
Nov 24, 2021
Completion
Nov 24, 2021
Last update
Feb 23, 2022

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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