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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
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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.
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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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Percentage of Patients Achieving the Adapted ACR Pediatric 90
Measure 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  
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.

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  
Percentage of Patients Achieving the Adapted ACR Pediatric 90  
[units: percent¬†of¬†participants]
   
Day 15     41.9     0  
Day 29     46.5     2.4  

No statistical analysis provided for Percentage of Patients Achieving the Adapted ACR Pediatric 90



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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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