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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02165345
Registration number
NCT02165345
Ethics application status
Date submitted
13/06/2014
Date registered
17/06/2014
Date last updated
23/02/2022
Titles & IDs
Public title
Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
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Scientific title
Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
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Secondary ID [1]
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2013-005212-98
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Secondary ID [2]
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WA29231
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab
Experimental: Tocilizumab - Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Juvenile Arthritis Disease Activity Score (JADAS-71)
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Assessment method [1]
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Timepoint [1]
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Baseline up to 3 years
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Primary outcome [2]
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Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest
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Assessment method [2]
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Timepoint [2]
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Baseline up to 5 years
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Secondary outcome [1]
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Childhood Health Assessment Questionnaire (CHAQ) Score
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Assessment method [1]
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Timepoint [1]
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Baseline up to 3 years
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Secondary outcome [2]
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Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission
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Assessment method [2]
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Timepoint [2]
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Baseline up to 3 years
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Eligibility
Key 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
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Minimum age
2
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/11/2021
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Sample size
Target
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Accrual to date
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Final
82
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Westmead Hospital; Paediatric Rheumatology - Westmead
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Recruitment hospital [2]
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Royal Children'S Hospital; Paediatric Rheumatology - Parkville
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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Arkansas
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United States of America
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Illinois
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Utah
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United States of America
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State/province [8]
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Washington
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Country [9]
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Argentina
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State/province [9]
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Buenos Aires
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Argentina
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Cordoba
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Brazil
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SP
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Canada
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Alberta
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Canada
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Ontario
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France
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Le Kremlin Bicêtre
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Germany
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Berlin
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Germany
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Freiburg
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Germany
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Sankt Augustin
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Italy
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Lazio
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Mexico
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Mexico
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Mexico
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Monterrey
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Bristol
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United Kingdom
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02165345
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02165345
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