ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
NCT ID: NCT02296424
Last Updated: 2019-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2014-11-17
2017-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Canakinumab Dose Reduction
All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab was administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continued to maintain inactive disease for 24 additional weeks, canakinumab was administered at 1mg/kg every 4 weeks. If the patient continued to maintain inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Canakinumab Dose Interval Prolongation
All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Interventions
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ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1
Cohort 2:
* Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease \< 16 years of age.
* Active SJIA defined as having 2 or more of the following:
* Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day within 1 week before first canakinumab dose;
* At least 2 joints with active arthritis
* C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L)
* Rash due to SJIA
* Serositis
* Lymphadenopathy
* Hepatosplenomegaly
* Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative).
Exclusion Criteria
* With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
* With neutropenia (absolute neutrophil count \< 1500/mm3) at screening.
2 Years
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Vienna, , Austria
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Brussels, , Belgium
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Laken, , Belgium
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Leuven, , Belgium
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Vancouver, British Colombia, Canada
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Toronto, Ontario, Canada
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Bron, , France
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Le Kremlin-Bicêtre, , France
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Paris, , France
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Sankt Augustin, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Bologna, BO, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Napoli, , Italy
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Utrecht, , Netherlands
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Málaga, Andalusia, Spain
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Esplugues de Llobregat, Barcelona, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Stockholm, , Sweden
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Istanbul, TUR, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Quartier P, Alexeeva E, Constantin T, Chasnyk V, Wulffraat N, Palmblad K, Wouters C, I Brunner H, Marzan K, Schneider R, Horneff G, Martini A, Anton J, Wei X, Slade A, Ruperto N, Abrams K; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study. Arthritis Rheumatol. 2021 Feb;73(2):336-346. doi: 10.1002/art.41488. Epub 2020 Dec 11.
Other Identifiers
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2013-004867-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CACZ885G2306
Identifier Type: -
Identifier Source: org_study_id
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