Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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7 March 2022 |
Main ID: |
NCT02165345 |
Date of registration:
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13/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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:
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Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis |
Date of first enrolment:
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July 16, 2014 |
Target sample size:
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82 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02165345 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Canada
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France
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Germany
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Italy
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Mexico
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Russian Federation
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: Tocilizumab
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Primary Outcome(s)
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Juvenile Arthritis Disease Activity Score (JADAS-71)
[Time Frame: Baseline up to 3 years]
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Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest
[Time Frame: Baseline up to 5 years]
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Secondary Outcome(s)
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Childhood Health Assessment Questionnaire (CHAQ) Score
[Time Frame: Baseline up to 3 years]
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Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission
[Time Frame: Baseline up to 3 years]
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Secondary ID(s)
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2013-005212-98
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WA29231
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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