Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
NCT ID: NCT00886769
Last Updated: 2017-03-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2009-07-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canakinumab
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
Canakinumab
Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
Placebo
Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.
Interventions
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Canakinumab
Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
Placebo
Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.
Other Intervention Names
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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/quotidian for at least 3 days and accompanied by one or more of the following:
* evanescent nonfixed erythematous rash,
* generalized lymph node enlargement,
* hepatomegaly and/ or splenomegaly,
* serositis
2. Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
3. Male and female patients aged ≥ 2 to \< 20 years of age
4. Active disease at the time of enrollment defined as follows:
* At least 2 joints with active arthritis
* Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
* C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L)
5. Naïve to canakinumab
Exclusion Criteria
1. Pregnant or nursing (lactating) female patients
2. Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
3. History of hypersensitivity to study drug or to biologics.
4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
5. With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
2 Years
19 Years
ALL
No
Sponsors
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Southwest Pediatric Nephrology Study Group
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital Research Inst
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, 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
Tufts Medical Center
Boston, Massachusetts, United States
Tufts New England Medical Center-Dept. of Allergy
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
Cinncinati, Ohio, United States
Nationwide Children's Hospital
Columbus, 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 Janeiro, , 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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Calgary, , Canada
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Arhus N, , Denmark
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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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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Garmisch-Partenkirch, , Germany
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Geißen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Krefeld, , Germany
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Mainz, , Germany
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Münster, , Germany
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Saint Augustin, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
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Thessaloniki, , Greece
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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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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)
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Birmingham, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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New Castle Upon Tyne, , United Kingdom
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Norwich, , United Kingdom
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Oxford, , United Kingdom
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
Other Identifiers
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EudraCT: 2008-005476-27
Identifier Type: -
Identifier Source: secondary_id
CACZ885G2305
Identifier Type: -
Identifier Source: org_study_id
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