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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:
ClinicalTrials.gov Identifier:
NCT00886769
First Posted: April 23, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Southwest Pediatric Nephrology Study Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: November 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Systemic Juvenile Idiopathic Arthritis
Interventions: Drug: Canakinumab
Drug: Placebo

  Participant Flow


  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 
Overall Participants Analyzed 
[Units: Participants]
 43   41   84 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.3  (5.08)   9.7  (4.32)   9.0  (4.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  62.8%      23  56.1%      50  59.5% 
Male      16  37.2%      18  43.9%      34  40.5% 


  Outcome Measures
  Show All Outcome Measures

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 ]


  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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