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

This study has been terminated.
(recommendation by Data Monitoring Committee)
Sponsor:
Collaborators:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Southwest Pediatric Nephrology Study Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00886769
First received: April 22, 2009
Last updated: March 13, 2012
Last verified: March 2012
Results First Received: November 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Systemic Juvenile Idiopathic Arthritis
Interventions: Drug: Canakinumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Placebo Patients received a single dose matching placebo of canakinumab on day 1.

Participant Flow:   Overall Study
    Canakinumab     Placebo  
STARTED     43     41  
COMPLETED     37     4  
NOT COMPLETED     6     37  
Unsatisfactory therapeutic effect                 6                 37  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Placebo Patients received a single dose matching placebo of canakinumab on day 1.
Total Total of all reporting groups

Baseline Measures
    Canakinumab     Placebo     Total  
Number of Participants  
[units: participants]
  43     41     84  
Age  
[units: years]
Mean ± Standard Deviation
  8.3  ± 5.08     9.7  ± 4.32     9.0  ± 4.75  
Gender  
[units: participants]
     
Female     27     23     50  
Male     16     18     34  



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria   [ Time Frame: Baseline, Day 15, Day 29 ]

2.  Secondary:   Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria   [ Time Frame: Baseline, Day 15, Day 29 ]

3.  Secondary:   Percentage of Patients Achieving the Adapted ACR Pediatric 70   [ Time Frame: Baseline, Day 15, Day 29 ]

4.  Secondary:   Percentage of Patients Achieving the Adapted ACR Pediatric 90   [ Time Frame: Baseline, Day 15, Day 29 ]

5.  Secondary:   Percentage of Patients Achieving the Adapted ACR Pediatric 100   [ Time Frame: baseline, Day 15, Day 29 ]

6.  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)   [ Time Frame: Baseline, Day 15 ]

7.  Secondary:   Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ   [ Time Frame: Baseline, Day 29 ]

8.  Secondary:   Percentage of Patients Who Had Body Temperature ≤ 38°C   [ Time Frame: Day 3 ]

9.  Secondary:   Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire – Parent Form (CHQ-PF50)   [ Time Frame: Over 4 week study period (Baseline, Day 15, Day 29) ]

10.  Secondary:   Change in Disability Score Over Time by Use of the CHAQ   [ Time Frame: At 4 week study period ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Change in Disability Score Over Time by Use of the CHAQ
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.

Reporting Groups
  Description
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.
Placebo Patients received a single dose matching placebo of canakinumab on day 1.

Measured Values
    Canakinumab     Placebo  
Number of Participants Analyzed  
[units: participants]
  43     41  
Change in Disability Score Over Time by Use of the CHAQ  
[units: Units on a Scale]
Least Squares Mean ± Standard Error
  -0.8  ± 0.15     -0.2  ± 0.20  

No statistical analysis provided for Change in Disability Score Over Time by Use of the CHAQ




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00886769     History of Changes
Other Study ID Numbers: CACZ885G2305, EudraCT: 2008-005476-27
Study First Received: April 22, 2009
Results First Received: November 21, 2011
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Ethics Committee