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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165345
• Other study ID #: WA29231
• Secondary ID: 2013-005212-98
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2014
• Est. completion date: November 24, 2021

Study information

• Verified date: February 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Argentina	Hospital Gral de Niños Pedro Elizalde	Buenos Aires
Argentina	Hospital de Ninos de la Santisima Trinidad; Hematología	Cordoba
Australia	Royal Children'S Hospital; Paediatric Rheumatology	Parkville	Victoria
Australia	Westmead Hospital; Paediatric Rheumatology	Westmead	New South Wales
Brazil	Hospital das Clinicas - FMUSP	Sao Paulo	SP
Brazil	Universidade Federal de Sao Paulo - UNIFES	Sao Paulo	SP
Canada	Alberta Children'S Hospital	Calgary	Alberta
Canada	The Hospital for Sick Children	Toronto	Ontario
France	CH de Bicêtre; Pediatrie Generale	Le Kremlin Bicêtre
Germany	Charité Campus; Virchow Klinikum Berlin	Berlin
Germany	Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie	Freiburg
Germany	Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie	Sankt Augustin
Italy	Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina	Roma	Lazio
Mexico	Hospital Infantil de México "Federico Gomez"; Rheumatology	Mexico
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria	Monterrey
Russian Federation	SI Sceintific children health center RAMS	Moscow
Spain	Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica	Esplugas DE Llobregat	Barcelona
Spain	Hospital de La Paz; Unidad de Reumatologia Pediatrica	Madrid
Spain	Hospital Ramon y Cajal ; Servicio de Reumatologia	Madrid
Spain	Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica	Valencia
United Kingdom	Bristol Royal Hospital for Children; Rheumatology Department	Bristol
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool
United States	University of Chicago Hospital	Chicago	Illinois
United States	Cincinnati Children'S Hospital Medical Center; Division of Rheumatology	Cincinnati	Ohio
United States	Cleveland Clinic Fndn	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Hackensack University Medical Center; Pediatric Rheumatology	Hackensack	New Jersey
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	University of Utah; Immunology/Rheumatology/Allergy	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington
United States	Healthcare Research Consultants	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Juvenile Arthritis Disease Activity Score (JADAS-71)		Baseline up to 3 years
Primary	Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest		Baseline up to 5 years
Secondary	Childhood Health Assessment Questionnaire (CHAQ) Score		Baseline up to 3 years
Secondary	Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission		Baseline up to 3 years