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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00886769
Other study ID # CACZ885G2305
Secondary ID EudraCT: 2008-00
Status Terminated
Phase Phase 3
First received April 22, 2009
Last updated March 13, 2012
Start date July 2009
Est. completion date January 2011

Study information

Verified date March 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Ministry of HealthBrazil: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: Ministry of HealthNorway: Norwegian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Peru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 84
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 19 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Capital Federal
Argentina Novartis Investigative Site La Plata
Belgium Novartis Investigative site Bruxelles
Belgium Novartis Investigative site Gent
Belgium Novartis Investigative Site Laeken
Belgium Novartis Investigative site Leuven
Brazil Novartis Investigative Site Curitiba
Brazil Novartis Investigative site Porto Alegre
Brazil Novartis Investigative site Rio de Janeiro
Brazil Novartis Investigative site Sao Paulo
Canada Novartis Investigative site Calgary
Canada Novartis Investigative site Halifax Nova Scotia
Canada Novartis Investigative site Montreal Quebec
Canada Novartis Investigative site Toronto Ontario
Canada Novartis Investigative site Vancouver British Columbia
Denmark Novartis Investigative site Arhus N
France Novartis Investigative Site Le Kremlin Bicetre
France Novartis Investigative Site Lyon
France Novartis Investigative Site Paris
France Novartis Investigative Site Strassbourg
Germany Novartis Investigative Site Bad Bamstedt
Germany Novartis Investigative site Berlin
Germany Novartis Investigative Site Bremen
Germany Novartis Investigative site Dresden
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative site Garmisch-Partenkirch
Germany Novartis Investigative Site Geissen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative site Hannover
Germany Novartis Investigative site Krefeld
Germany Novartis Investigative site Mainz
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Saint Augustin
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative site Tubingen
Greece Novartis Investigative site Thessaloniki
Hungary Novartis Investigative Site Budapest
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Kfar Saba
Israel Novartis Investigative Site Petach-Tikva
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Rehovot
Italy Novartis Investigative Site Bologna
Italy Novartis Investigative Site Firenze
Italy Novartis Investigative Site Genova
Italy Novartis Investigative site Milano
Italy Novartis Investigative site Napoli
Italy Novartis Investigative site Padova
Italy Novartis Investigative site Rome
Italy Novartis Investigative site Scafati
Italy Novartis Investigative site Torino
Netherlands Novartis Investigative site Utrecht
Norway Novartis Investigative Site Oslo
Peru Novartis Investigative Site Lima
Poland Novartis Investigative site Warszawa
South Africa Novartis Investigative site Berea Durban
South Africa Novartis Investigative site Mayville Durban
South Africa Novartis Investigative site Pretoria
Spain Novartis Investigative site Barcelona
Spain Novartis Investigative site Madrid
Spain Novartis Investigative site Valencia
Sweden Novartis Investigative site Stockholm
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative site Lausanne
Switzerland Novartis Investigative site Zurich
Turkey Novartis Investigative site Ankara
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
United Kingdom Novartis Investigative site Birmingham
United Kingdom Novartis Investigative site Liverpool
United Kingdom Novartis Investigative site London
United Kingdom Novartis Investigative site Manchester
United Kingdom Novartis Investigative site New Castle Upon Tyne
United Kingdom Novartis Investigative site Norwich
United Kingdom Novartis Investigative site Oxford
United States Specially For Children Austin Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Tufts New England Medical Center-Dept. of Allergy Boston Massachusetts
United States University of Chicago Medical Center Chicago Illinois
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 Arkansas Children's Hospital Research Inst Little Rock Arkansas
United States St. Barnabas Ambulatory Care Center Livingston New Jersey
United States Children's Hospital Los Angeles Los Angeles California
United States University of Louisville Louisville Kentucky
United States Legacy Emanual Research Portland Oregon
United States Legacy Emanuel Hospital Portland Oregon
United States Children's National Medical Center Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
Novartis Pharmaceuticals International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Southwest Pediatric Nephrology Study Group

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Peru,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline, Day 15, Day 29 No
Secondary 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) Baseline, Day 15, Day 29 No
Secondary 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) Baseline, Day 15, Day 29 No
Secondary 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) Baseline, Day 15, Day 29 No
Secondary 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 baseline, Day 15, Day 29 No
Secondary 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. Baseline, Day 15 No
Secondary 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. Baseline, Day 29 No
Secondary 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. Day 3 No
Secondary 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. Over 4 week study period (Baseline, Day 15, Day 29) No
Secondary 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. At 4 week study period No
See also
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Completed NCT01304420 - Ultrasonography in Juvenile Idiopathic Arthritis Phase 0
Completed NCT02334748 - A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies Phase 3
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