Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
NCT ID: NCT02165345
Last Updated: 2022-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2014-07-16
2021-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tocilizumab
Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.
Tocilizumab
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
Interventions
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Tocilizumab
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of Chicago Hospital
Chicago, Illinois, United States
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, United States
Cleveland Clinic Fndn
Cleveland, Ohio, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University of Utah; Immunology/Rheumatology/Allergy
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital Gral de Niños Pedro Elizalde
Buenos Aires, , Argentina
Hospital de Ninos de la Santisima Trinidad; Hematología
Córdoba, , Argentina
Westmead Hospital; Paediatric Rheumatology
Westmead, New South Wales, Australia
Royal Children'S Hospital; Paediatric Rheumatology
Parkville, Victoria, Australia
Universidade Federal de Sao Paulo - UNIFES
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Alberta Children'S Hospital
Calgary, Alberta, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CH de Bicêtre; Pediatrie Generale
Le Kremlin-Bicêtre, , France
Charité Campus; Virchow Klinikum Berlin
Berlin, , Germany
Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie
Freiburg im Breisgau, , Germany
Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie
Sankt Augustin, , Germany
Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina
Rome, Lazio, Italy
Hospital Infantil de México "Federico Gomez"; Rheumatology
México, , Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, , Mexico
SI Sceintific children health center RAMS
Moscow, , Russia
Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica
Esplugas de Llobregat, Barcelona, Spain
Hospital Ramon y Cajal ; Servicio de Reumatologia
Madrid, , Spain
Hospital de La Paz; Unidad de Reumatologia Pediatrica
Madrid, , Spain
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, , Spain
Bristol Royal Hospital for Children; Rheumatology Department
Bristol, , United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, , United Kingdom
Countries
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References
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Brunner HI, Ruperto N, Ramanan AV, Horneff G, Minden K, Calvo Penades I, Alexeeva E, Cleary G, Stern SM, Kone-Paut I, Maldonado Velazquez MDR, Rabinovich CE, Remesal A, Silva CA, Nikishina I, Zucchetto M, Brockwell L, Gordon O, Nagel S, De Benedetti F; PRINTO and PRCSG Investigators. Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Sep 1;63(9):2535-2546. doi: 10.1093/rheumatology/keae180.
Other Identifiers
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2013-005212-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA29231
Identifier Type: -
Identifier Source: org_study_id
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