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

NCT02165345 | Completed Phase 1

• 2 other identifiers: WA292312013-005212-98
• Study Type: interventional
• Target: 82
• Locations: 12 countries
• Sites: 31

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (2)

• Juvenile Arthritis Disease Activity Score (JADAS-71)

  Baseline up to 3 years

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

  Baseline up to 5 years

Secondary Outcomes (2)

• Childhood Health Assessment Questionnaire (CHAQ) Score

  Baseline up to 3 years

• Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission

  Baseline up to 3 years

Study Arms (1)

Tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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

Tocilizumab

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (31)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Hackensack University Medical Center; Pediatric Rheumatology

Hackensack, New Jersey, 07601, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

Cincinnati, Ohio, 45229-3039, United States

Location

Cleveland Clinic Fndn

Cleveland, Ohio, 44195, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

Location

University of Utah; Immunology/Rheumatology/Allergy

Salt Lake City, Utah, 84109, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Hospital Gral de Niños Pedro Elizalde

Buenos Aires, C1270AAN, Argentina

Location

Hospital de Ninos de la Santisima Trinidad; Hematología

Córdoba, X5000XAF, Argentina

Location

Westmead Hospital; Paediatric Rheumatology

Westmead, New South Wales, 2145, Australia

Location

Royal Children'S Hospital; Paediatric Rheumatology

Parkville, Victoria, 3052, Australia

Location

Universidade Federal de Sao Paulo - UNIFES

São Paulo, São Paulo, 04026-000, Brazil

Location

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

Alberta Children'S Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CH de Bicêtre; Pediatrie Generale

Le Kremlin-Bicêtre, 94275, France

Location

Charité Campus; Virchow Klinikum Berlin

Berlin, 13353, Germany

Location

Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie

Freiburg im Breisgau, 79106, Germany

Location

Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie

Sankt Augustin, 53757, Germany

Location

Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

Rome, Lazio, 00165, Italy

Location

Hospital Infantil de México "Federico Gomez"; Rheumatology

México, 06720, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

Monterrey, 64460, Mexico

Location

SI Sceintific children health center RAMS

Moscow, 119991, Russia

Location

Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

Esplugas de Llobregat, Barcelona, 08950, Spain

Location

Hospital Ramon y Cajal ; Servicio de Reumatologia

Madrid, 28034, Spain

Location

Hospital de La Paz; Unidad de Reumatologia Pediatrica

Madrid, 28046, Spain

Location

Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

Valencia, 46026, Spain

Location

Bristol Royal Hospital for Children; Rheumatology Department

Bristol, BS2 8BJ, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust

Liverpool, L12 2AP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38552315 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: July 16, 2014
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

ME (2); RU (1); AU (2); US (9); CA (2); ES (4); DE (3); IT (1); BR (2); FR (1); AR (2); GB (2)