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Completed

NCT Number: NCT02165345

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

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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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Gral de Niños Pedro Elizalde, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: RoActemra, Actemra

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2014
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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