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Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

Primary Purpose

Systemic Juvenile Idiopathic Arthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canakinumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis focused on measuring Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile Rheumatoid, Systemic juvenile idiopathic arthritis with active flare

Eligibility Criteria

2 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age:

    • 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
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:

  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
  6. Other protocol defined exclusion criteria may apply

Sites / Locations

  • University of Alabama at Birmingham
  • Arkansas Children's Hospital Research Inst
  • Children's Hospital Los Angeles
  • Children's National Medical Center
  • University of Chicago Medical Center
  • University of Louisville
  • Tufts Medical Center
  • Tufts New England Medical Center-Dept. of Allergy
  • St. Barnabas Ambulatory Care Center
  • Children's Hospital Medical Center
  • Children's Hospital/Neurology
  • Nationwide Children's Hospital
  • Legacy Emanuel Hospital
  • Legacy Emanual Research
  • Specially For Children
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canakinumab

Placebo

Arm Description

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.

Patients received a single dose matching placebo of canakinumab on day 1.

Outcomes

Primary Outcome Measures

Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)

Secondary Outcome Measures

Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Percentage of Patients Achieving the Adapted ACR Pediatric 70
Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Percentage of Patients Achieving the Adapted ACR Pediatric 90
Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Percentage of Patients Achieving the Adapted ACR Pediatric 100
Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)
CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ
CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Percentage of Patients Who Had Body Temperature ≤ 38°C
Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.
Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
Change in Disability Score Over Time by Use of the CHAQ
The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.

Full Information

First Posted
April 22, 2009
Last Updated
February 28, 2017
Sponsor
Novartis Pharmaceuticals
Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Southwest Pediatric Nephrology Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00886769
Brief Title
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
Acronym
β-SPECIFIC 1
Official Title
A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
recommendation by Data Monitoring Committee
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Southwest Pediatric Nephrology Study Group

4. Oversight

5. Study Description

Brief Summary
This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Juvenile Idiopathic Arthritis
Keywords
Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile Rheumatoid, Systemic juvenile idiopathic arthritis with active flare

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canakinumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received a single dose matching placebo of canakinumab on day 1.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Other Intervention Name(s)
ACZ885
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Description
Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Time Frame
Baseline, Day 15, Day 29
Secondary Outcome Measure Information:
Title
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Description
Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Time Frame
Baseline, Day 15, Day 29
Title
Percentage of Patients Achieving the Adapted ACR Pediatric 70
Description
Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Time Frame
Baseline, Day 15, Day 29
Title
Percentage of Patients Achieving the Adapted ACR Pediatric 90
Description
Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Time Frame
Baseline, Day 15, Day 29
Title
Percentage of Patients Achieving the Adapted ACR Pediatric 100
Description
Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
Time Frame
baseline, Day 15, Day 29
Title
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)
Description
CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Time Frame
Baseline, Day 15
Title
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ
Description
CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Time Frame
Baseline, Day 29
Title
Percentage of Patients Who Had Body Temperature ≤ 38°C
Description
Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.
Time Frame
Day 3
Title
Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
Description
CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
Time Frame
Over 4 week study period (Baseline, Day 15, Day 29)
Title
Change in Disability Score Over Time by Use of the CHAQ
Description
The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.
Time Frame
At 4 week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age: 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 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 Male and female patients aged ≥ 2 to < 20 years of age 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) Naïve to canakinumab Other protocol defined inclusion criteria may apply Exclusion Criteria: Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study: Pregnant or nursing (lactating) female patients 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 History of hypersensitivity to study drug or to biologics. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months 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 Other protocol defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arkansas Children's Hospital Research Inst
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Tufts New England Medical Center-Dept. of Allergy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Barnabas Ambulatory Care Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital/Neurology
City
Cinncinati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Legacy Emanuel Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Legacy Emanual Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Specially For Children
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Capital Federal
Country
Argentina
Facility Name
Novartis Investigative Site
City
La Plata
Country
Argentina
Facility Name
Novartis Investigative site
City
Bruxelles
Country
Belgium
Facility Name
Novartis Investigative site
City
Gent
Country
Belgium
Facility Name
Novartis Investigative Site
City
Laeken
Country
Belgium
Facility Name
Novartis Investigative site
City
Leuven
Country
Belgium
Facility Name
Novartis Investigative Site
City
Curitiba
Country
Brazil
Facility Name
Novartis Investigative site
City
Porto Alegre
Country
Brazil
Facility Name
Novartis Investigative site
City
Rio de Janeiro
Country
Brazil
Facility Name
Novartis Investigative site
City
Sao Paulo
Country
Brazil
Facility Name
Novartis Investigative site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Novartis Investigative site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Novartis Investigative site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative site
City
Calgary
Country
Canada
Facility Name
Novartis Investigative site
City
Arhus N
Country
Denmark
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Strassbourg
Country
France
Facility Name
Novartis Investigative Site
City
Bad Bamstedt
Country
Germany
Facility Name
Novartis Investigative site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
Country
Germany
Facility Name
Novartis Investigative site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
Country
Germany
Facility Name
Novartis Investigative site
City
Garmisch-Partenkirch
Country
Germany
Facility Name
Novartis Investigative Site
City
Geissen
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative site
City
Krefeld
Country
Germany
Facility Name
Novartis Investigative site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
Country
Germany
Facility Name
Novartis Investigative Site
City
Saint Augustin
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
Country
Germany
Facility Name
Novartis Investigative site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative site
City
Thessaloniki
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Haifa
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach-Tikva
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
Country
Israel
Facility Name
Novartis Investigative Site
City
Bologna
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
Country
Italy
Facility Name
Novartis Investigative site
City
Milano
Country
Italy
Facility Name
Novartis Investigative site
City
Napoli
Country
Italy
Facility Name
Novartis Investigative site
City
Padova
Country
Italy
Facility Name
Novartis Investigative site
City
Rome
Country
Italy
Facility Name
Novartis Investigative site
City
Scafati
Country
Italy
Facility Name
Novartis Investigative site
City
Torino
Country
Italy
Facility Name
Novartis Investigative site
City
Utrecht
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Oslo
Country
Norway
Facility Name
Novartis Investigative Site
City
Lima
Country
Peru
Facility Name
Novartis Investigative site
City
Warszawa
Country
Poland
Facility Name
Novartis Investigative site
City
Berea
State/Province
Durban
Country
South Africa
Facility Name
Novartis Investigative site
City
Mayville
State/Province
Durban
Country
South Africa
Facility Name
Novartis Investigative site
City
Pretoria
Country
South Africa
Facility Name
Novartis Investigative site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative site
City
Stockholm
Country
Sweden
Facility Name
Novartis Investigative Site
City
Bern
Country
Switzerland
Facility Name
Novartis Investigative site
City
Lausanne
Country
Switzerland
Facility Name
Novartis Investigative site
City
Zurich
Country
Switzerland
Facility Name
Novartis Investigative site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative site
City
Birmingham
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Liverpool
Country
United Kingdom
Facility Name
Novartis Investigative site
City
London
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigative site
City
New Castle Upon Tyne
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Norwich
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30269054
Citation
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.
Results Reference
derived
PubMed Identifier
28115015
Citation
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.
Results Reference
derived
PubMed Identifier
26314396
Citation
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.
Results Reference
derived
PubMed Identifier
23252526
Citation
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.
Results Reference
derived
Links:
URL
http://www.NovartisClinicalTrials.com
Description
Click here for more information about this study
URL
http://www.juvenilearthritisresearch.com
Description
Related Info

Learn more about this trial

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

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