Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT ID: NCT00889863
Last Updated: 2012-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2009-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canakinumab
In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
canakinumab
Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.
Placebo
Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
placebo
Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
Interventions
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canakinumab
Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.
placebo
Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
Eligibility Criteria
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Inclusion Criteria
-Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
* Active disease at the time of enrollment defined as follows:
* At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint)
* Documented spiking, intermittent fever (body temperature \> 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
* C-reactive protein \> 30 mg/L (normal range \< 10 mg/L)
* No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
* Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
* Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
* Stable dose of steroid treatment \< or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
Exclusion Criteria
* Risk factors for tuberculosis
* Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection
2 Years
19 Years
ALL
No
Sponsors
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Pediatric Rheumatology International Trials Organization
OTHER
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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Arkansas Children's Hospital Research Inst
Little Rock, Arkansas, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
New England Medical Center - Department of Allergy
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
St Barnabas Ambulatory Care Center
Livingston, New Jersey, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital/Neurology
Cincinnati, Ohio, United States
Legacy Emanuel Hospital
Portland, Oregon, United States
Legacy Emanual Research
Portland, Oregon, United States
Specially For Children
Austin, Texas, United States
Novartis Investigative Site
Buenos Aires, , Argentina
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Capital Federal, , Argentina
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La Plata, , Argentina
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Brussels, , Belgium
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Ghent, , Belgium
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Laken, , Belgium
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Leuven, , Belgium
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Rio de Janiero, , Brazil
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São Paulo, , Brazil
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Le Kremlin-Bicêtre, , France
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Lyon, , France
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Paris, , France
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Strasbourg, , France
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Bad Bamstedt, , Germany
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Berlin, , Germany
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Bremen, , Germany
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Freiburg im Breisgau, , Germany
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Geißen, , Germany
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Hamburg, , Germany
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Münster, , Germany
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Saint Augustin, , Germany
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Stuttgart, , Germany
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Budapest, , Hungary
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Haifa, , 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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Rehovot, , Israel
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Bologna, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Rome, , Italy
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Scafati, , Italy
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Torino, , Italy
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Utrecht, , Netherlands
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Oslo, , Norway
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Lima, , Peru
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Warsaw, , Poland
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Berea, Durban, South Africa
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Mayville, Durban, South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Stockholm, , Sweden
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Bern, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Countries
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References
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Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29.
Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x.
Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group; Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407.
Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099.
Related Links
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Related Info
Related Info
Other Identifiers
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EudraCT: 2008-005479-82
Identifier Type: -
Identifier Source: secondary_id
CACZ885G2301
Identifier Type: -
Identifier Source: org_study_id