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An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. (β-SPECIFIC 3)

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ClinicalTrials.gov Identifier: NCT00891046
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : March 10, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Pediatric Rheumatology International Trials Organization
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Juvenile Idiopathic Arthritis
Intervention Drug: Canakinumab
Enrollment 270
Recruitment Details The study was conducted at 61 centres in 20 countries.
Pre-assignment Details A total of 147 participants from studies CACZ885G2301 (NCT number: NCT00889863) and CACZ885G2305 (NCT number: NCT00886769) and 123 canakinumab treatment­ naive participants were enrolled into this extension study.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description Participants who discontinued from Study CACZ885G2301 Part 2 (NCT00889863) due to SJIA flare, received a subcutaneous (s.c.). Participants who completed Study CACZ885G2301 (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who failed to taper their steroid dose in CACZ885G2301 (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Period Title: Overall Study
Started 33 63 40 11 123
Completed 21 54 17 8 84
Not Completed 12 9 23 3 39
Reason Not Completed
Protocol Violation             1             1             0             0             1
Unsatisfactory therapeutic effect             5             2             19             2             20
Administrative problems             0             0             0             0             1
Participant no longer required drug             0             2             0             0             1
Adverse Event             4             3             2             0             14
Withdrawal by Subject             2             1             2             1             1
Lost to Follow-up             0             0             0             0             1
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive Total
Hide Arm/Group Description Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Participants who were canakinumab treatment­ naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. Total of all reporting groups
Overall Number of Baseline Participants 33 63 40 11 123 270
Hide Baseline Analysis Population Description
Safety Set: The analysis was performed in safety set (SAF), defined as all participants who received at least one dose of study drug.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 63 participants 40 participants 11 participants 123 participants 270 participants
2 ­- <4 years 0 2 3 1 18 24
4 ­- <6 years 6 10 6 5 15 42
6 ­- <12 years 16 32 21 3 50 122
12 ­- <20 years 11 17 10 2 40 80
≥ 20 years 0 2 0 0 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 63 participants 40 participants 11 participants 123 participants 270 participants
Female
19
  57.6%
34
  54.0%
23
  57.5%
5
  45.5%
75
  61.0%
156
  57.8%
Male
14
  42.4%
29
  46.0%
17
  42.5%
6
  54.5%
48
  39.0%
114
  42.2%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE
Hide Description An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator.
Time Frame From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in safety set (SS), defined as all participants who received at least one dose of study drug.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 147
Measure Type: Number
Unit of Measure: participants
AEs 108 137
SAEs 40 47
Discontinuation due to any AE 14 18
Discontinuation due to any SAE 13 14
Treatment Related AEs 44 57
Treatment related SAEs 1 4
2.Primary Outcome
Title Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study
Hide Description Immunogenicity assessment included determination of anti­canakinumab (ACZ885) antibodies in serum samples using BIAcore system.
Time Frame From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the SS population.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 147
Measure Type: Number
Unit of Measure: participants
0 0
3.Primary Outcome
Title Number of Participants With Clinically Significant Local Injection Site Reactions During the Study
Hide Description Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion.
Time Frame From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in SS population.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 147
Measure Type: Number
Unit of Measure: participants
No tolerability reaction 115 129
Mild tolerability reaction 6 15
Moderate tolerability reaction 2 3
Severe tolerability reaction 0 0
4.Primary Outcome
Title Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Hide Description Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (SJIA) during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.
Arm/Group Title ACZ885 Treatment Naive: Group 1 ACZ885 Treatment Naive: Group 2 ACZ885 Treatment Naive: Group 3 ACZ885 Treatment Naive: Group 4
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and who discontinued anakinra due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who never exposed to anakinra, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 26 12 13 70
Measure Type: Number
Unit of Measure: Percentage of participants
ACR ≥30 criteria 80.8 91.7 100 95.7
ACR ≥ 50 criteria 80.8 91.7 100 92.9
ACR ≥ 70 criteria 76.9 91.7 92.3 90
ACR ≥ 90 criteria 69.2 91.7 76.9 80
ACR 100 criteria 57.7 91.7 69.2 64.3
5.Primary Outcome
Title Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Hide Description Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.
Arm/Group Title ACZ885 Treatment Naive: Group 1 ACZ885 Treatment Naive: Group 2 ACZ885 Treatment Naive: Group 3 ACZ885 Treatment Naive: Group 4
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and who discontinued tocilizumab due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who never exposed to tocilizumab, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 26 3 2 90
Measure Type: Number
Unit of Measure: Percentage of participants
ACR ≥30 criteria 92.3 100 100 92.2
ACR ≥ 50 criteria 88.5 100 100 91.1
ACR ≥ 70 criteria 88.5 100 100 86.7
ACR ≥ 90 criteria 88.5 66.7 50 76.7
ACR 100 criteria 65.4 66.7 0 67.8
6.Primary Outcome
Title Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Hide Description Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treatment naive: Group 2' there were no participants who had discontinued other biologics due to safety/tolerability issues.
Arm/Group Title ACZ885 Treatment Naive: Group 1 ACZ885 Treatment Naive: Group 2 ACZ885 Treatment Naive: Group 3 ACZ885 Treatment Naive: Group 4
Hide Arm/Group Description:
Participants who were canakinumab treatment­ naive and who discontinued other biologics due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued other biologics for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who discontinued other biologics for other reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and who never exposed to other biologics, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 30 0 2 89
Measure Type: Number
Unit of Measure: Percentage of participants
ACR ≥30 criteria 96.7 100 91.0
ACR ≥ 50 criteria 93.3 50 91.0
ACR ≥ 70 criteria 86.7 50 88.8
ACR ≥ 90 criteria 83.3 50 77.5
ACR 100 criteria 60 50 68.5
7.Secondary Outcome
Title Percentage of Non-­Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100
Hide Description Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of ­CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treated: Group 2 (Completed core study)' there were no Non-Responders participants available.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 17 0 17 6 121
Measure Type: Number
Unit of Measure: Percentage of participants
ACR ≥30 criteria 82.4 76.5 83.3 92.6
ACR ≥ 50 criteria 82.4 70.6 83.3 90.9
ACR ≥ 70 criteria 82.4 52.9 83.3 87.6
ACR ≥ 90 criteria 76.5 23.5 50 78.5
ACR 100 criteria 58.8 17.6 50 66.1
8.Secondary Outcome
Title Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study
Hide Description Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria)
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 16 63 23 5
Measure Type: Number
Unit of Measure: Percentage of participants
ACR ≥ 30 100 100 91.3 100
ACR ≥ 50 100 100 87 100
ACR ≥ 70 100 100 78.3 100
ACR ≥ 90 100 100 69.6 100
ACR ≥ 100 87.5 93.7 39.1 80
9.Secondary Outcome
Title Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen
Hide Description Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants who were steroid users at baseline.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 11 9 38 8 71
Measure Type: Number
Unit of Measure: Percentage of participants
Steroid free 36.4 55.6 23.7 25 33.8
Successfully tapered 27.3 0 21.1 25 23.9
Unsuccessfully tapered 18.2 22.2 18.4 25 11.3
Did not taper 18.2 22.2 36.8 25 31
10.Secondary Outcome
Title Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg
Hide Description The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 33 63 40 11 123
Measure Type: Number
Unit of Measure: participants
9 29 4 2 18
11.Secondary Outcome
Title Percentage of Participants With Clinical Remission
Hide Description Clinical remission was defined as at least 6 months of inactive disease or at least 12 months of inactive disease on medication during the extension period. Participants with inactive disease for at least 6 months, but had loss of inactive disease before 12 months were also determined.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 147
Measure Type: Number
Unit of Measure: Percentage of participants
At least 6 consecutive months of inactive disease 42.3 52.4
At least 12 consecutive months of inactive disease 26.8 42.9
Loss of inactive disease after 6 months 8.9 6.8
12.Secondary Outcome
Title Change From Baseline in Disability, Overall Well­Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study
Hide Description The CHAQ was used to assess physical ability, overall well- being and pain intensity experienced by participants. The CHAQ (disability and well-being) dimension consisted of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Participants were graded for the response in four categories, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Participant’s pain intensity was assessed by parents and adult participants (18­20 years old) on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). Change from baseline was calculated by using the formula = (post baseline value – baseline value). For both scales, lower scores indicate increased functional ability.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 33 63 40 11 121
Median (Full Range)
Unit of Measure: units on a scale
Disability score
-0.375
(-2 to 0.625)
0
(-1.5 to 2.125)
-0.125
(-1.25 to 2.25)
0
(-2.125 to 1.375)
-0.7143
(-3 to 2.5)
Overall well­being score
-18
(-64 to 54)
0
(-36 to 81)
0
(-36 to 1)
-10
(-69 to 20)
-28
(-100 to 83)
Pain Intensity score
-13
(-69 to 39)
0
(-39 to 80)
0
(-58 to 93)
0
(-57 to 53)
-39
(-100 to 89)
13.Secondary Outcome
Title Change From Baseline in Health­Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire­ Parent Form (CHQ­PF50) to Last Assessment of Study
Hide Description The Child Health Questionnaire – Parent Form (CHQ­PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent’s perspective. This 14 concept questionnaire measured physical and psychosocial health of the participants on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact ­ emotional, parental impact – time, family activities, and family cohesion. Total score ranged from 1-100. Increase in score represented improvement in overall well being of participants. Change from baseline was calculated by using the formula = (post baseline value – baseline value).
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with HRQoL assessment in the given visit.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 26 44 29 8 90
Median (Full Range)
Unit of Measure: units on a scale
CHQ­PF50 physical score
14.0407
(-18.289 to 38.33)
0.6959
(-14.663 to 23.833)
1.3716
(-42.009 to 41.275)
13.9255
(-3.074 to 37.083)
18.8758
(-38.587 to 60.661)
CHQ­PF50 psychosocial score
3.8815
(-22.516 to 22.471)
1.4004
(-14.99 to 30.982)
0.7582
(-21.674 to 22.907)
11.9798
(-5.931 to 33.497)
9.3209
(-23.862 to 48.657)
14.Secondary Outcome
Title Change From Baseline in EuroQual 5 ­Dimension Health Status Questionnaire (EQ­5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study
Hide Description

EQ-5D HRQoL tool was used for participants above 12 years and EQ-5D proxy for 8-11 years. EQ-5D index scores range from -0.11 (worst possible health, worse than dead), to 0 (dead) to 1 (perfect health). Utility based EQ-5D questionnaire provides generic measure of health for clinical and economic appraisal based on 2 parts: EQ-5D descriptive system - 5 dimensions each with 3 levels (1:no, 2:moderate, 3:severe problem) on: mobility (1=0, 2=0.069, 3=0.314), self-care (1=0, 2=0.104, 3=0.214), usual activities (1=0, 2=0.036, 3=0.094), pain/discomfort (1=0, 2=0, 3=0.386) and anxiety/depression (1=0, 2=0.071, 3=0.2). EQ-5D Total score= 1-0.081-(score of level 2 in present)-0.269 (if at least one of level 3 presents). EQ-5D total score: 1=high quality of life; -0.59 worst quality of life; and EQ-VAS - record participant's self-rated health on vertical, visual analog scale as '100=Best and 0=Worst imaginable health state'.

Positive change from baseline score indicated improved health status.

Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'Number of participants analyzed' signifies number of participants with EQ­5D assessment in the given visit.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 17 35 22 4 65
Median (Full Range)
Unit of Measure: units on a scale
EQ­ 5D Utility Index
0.204
(-0.636 to 0.945)
0
(-0.434 to 0.377)
0.069
(-1.181 to 0.508)
0.2385
(0 to 0.741)
0.228
(-0.434 to 1.291)
EQ-VAS
21
(-45 to 63)
0
(-17 to 49)
5
(-86 to 50)
28
(0 to 65)
30
(-24 to 95)
15.Secondary Outcome
Title Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study
Hide Description Sleep patterns in children and adolescents aged between 11 and 15 years were determined using PDSS instrument to evaluate whether canakinumab helps in reducing sleepiness in children with SJIA. Participants were assessed on 8 items of PDSS, on a scale of 0 to 4 (0 - never, 1 - seldom, 2- sometimes, 3 - frequently and 4 - always). The sum of all the items was reported as total score with a range of 0-32. Change from baseline was calculated by using the formula = (post baseline value - baseline value). A positive change from baseline score indicated improvement.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here, ‘Number of participants analysed’ signifies those participants with a value at both baseline and the respective post baseline time point and with an assessment of PDSS score in the given visit..
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria)
Hide Arm/Group Description:
Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 9 12 5 2
Median (Full Range)
Unit of Measure: units on a scale
1
(-9 to 4)
0.5
(-6 to 9)
0
(-4 to 6)
-4.5
(-11 to 2)
16.Secondary Outcome
Title Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study
Hide Description Growth velocity parameter height percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 139
Median (Full Range)
Unit of Measure: Percentile
-0.01
(-66.18 to 47.06)
0
(-37.94 to 37.12)
17.Secondary Outcome
Title Percentage of Participants With Inactive Disease
Hide Description Inactive disease was defined as no joints with active arthritis; no fever (body temperature ≤ 38 degree Celsius); no rheumatoid rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to SJIA; normal CRP, and a rating of no disease activity on the Physician’s Global Assessment of disease activity (with a best possible score ≤10 mm on the VAS).
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.
Arm/Group Title ACZ885 Treated: Group 1 (Discontinued From Core Study) ACZ885 Treated: Group 2 (Completed Core Study) ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) ACZ885 Treated: Group 4 (Other Criteria) ACZ885 Treatment Naive
Hide Arm/Group Description:
Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Overall Number of Participants Analyzed 33 63 40 11 122
Measure Type: Number
Unit of Measure: Percentage of participants
39.4 79.4 12.5 36.4 50.8
18.Secondary Outcome
Title Change From Baseline in Growth Velocity Parameters to Last Assessment of Study
Hide Description Growth velocity parameter weight percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 139
Median (Full Range)
Unit of Measure: Percentile
0.1
(-47.35 to 82.84)
0
(-62.49 to 56.87)
19.Secondary Outcome
Title Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study
Hide Description Growth velocity parameter BMI percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Time Frame Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.
Arm/Group Title ACZ885 Treatment Naive ACZ885 Treated
Hide Arm/Group Description:
Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
Overall Number of Participants Analyzed 123 139
Median (Full Range)
Unit of Measure: Percentile
1.08
(-66.95 to 76.3)
-0.77
(-72.88 to 88.47)
Time Frame From start of study treatment (Day 1) to end of follow-up period (Week 271)
Adverse Event Reporting Description The analysis was performed in safety set, defined as all subjects who received at least one dose of study drug under this study protocol.
 
Arm/Group Title ACZ885 Treated ACZ885 Treatment Naive
Hide Arm/Group Description Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4. Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
All-Cause Mortality
ACZ885 Treated ACZ885 Treatment Naive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACZ885 Treated ACZ885 Treatment Naive
Affected / at Risk (%) Affected / at Risk (%)
Total   47/147 (31.97%)   40/123 (32.52%) 
Blood and lymphatic system disorders     
Abdominal lymphadenopathy  1  0/147 (0.00%)  1/123 (0.81%) 
Anaemia  1  0/147 (0.00%)  1/123 (0.81%) 
Histiocytosis haematophagic  1  10/147 (6.80%)  6/123 (4.88%) 
Leukopenia  1  1/147 (0.68%)  2/123 (1.63%) 
Lymphadenitis  1  0/147 (0.00%)  3/123 (2.44%) 
Lymphadenopathy  1  1/147 (0.68%)  3/123 (2.44%) 
Neutropenia  1  0/147 (0.00%)  1/123 (0.81%) 
Splenomegaly  1  1/147 (0.68%)  0/123 (0.00%) 
Thrombocytopenia  1  1/147 (0.68%)  1/123 (0.81%) 
Cardiac disorders     
Pericardial effusion  1  0/147 (0.00%)  1/123 (0.81%) 
Pericarditis  1  1/147 (0.68%)  0/123 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/147 (1.36%)  1/123 (0.81%) 
Abdominal pain upper  1  0/147 (0.00%)  1/123 (0.81%) 
Colitis  1  0/147 (0.00%)  1/123 (0.81%) 
Colitis ulcerative  1  0/147 (0.00%)  1/123 (0.81%) 
Enteritis  1  0/147 (0.00%)  1/123 (0.81%) 
Gastrointestinal disorder  1  0/147 (0.00%)  1/123 (0.81%) 
Gastrooesophageal reflux disease  1  1/147 (0.68%)  0/123 (0.00%) 
Hiatus hernia  1  1/147 (0.68%)  0/123 (0.00%) 
General disorders     
Device dislocation  1  0/147 (0.00%)  1/123 (0.81%) 
Disease progression  1  1/147 (0.68%)  0/123 (0.00%) 
Drug ineffective  1  1/147 (0.68%)  1/123 (0.81%) 
Injury associated with device  1  0/147 (0.00%)  1/123 (0.81%) 
Pyrexia  1  5/147 (3.40%)  4/123 (3.25%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  1/147 (0.68%)  0/123 (0.00%) 
Hepatitis  1  2/147 (1.36%)  0/123 (0.00%) 
Hepatitis toxic  1  0/147 (0.00%)  1/123 (0.81%) 
Hepatocellular injury  1  0/147 (0.00%)  1/123 (0.81%) 
Hepatomegaly  1  1/147 (0.68%)  0/123 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/147 (0.00%)  1/123 (0.81%) 
Infections and infestations     
Abscess neck  1  0/147 (0.00%)  1/123 (0.81%) 
Appendicitis  1  1/147 (0.68%)  0/123 (0.00%) 
Bronchopneumonia  1  0/147 (0.00%)  1/123 (0.81%) 
Cellulitis  1  0/147 (0.00%)  1/123 (0.81%) 
Cytomegalovirus hepatitis  1  1/147 (0.68%)  0/123 (0.00%) 
Cytomegalovirus infection  1  1/147 (0.68%)  1/123 (0.81%) 
Device related sepsis  1  1/147 (0.68%)  0/123 (0.00%) 
Escherichia urinary tract infection  1  0/147 (0.00%)  1/123 (0.81%) 
Furuncle  1  0/147 (0.00%)  1/123 (0.81%) 
Gastroenteritis  1  4/147 (2.72%)  2/123 (1.63%) 
Gastroenteritis salmonella  1  1/147 (0.68%)  0/123 (0.00%) 
Gastroenteritis yersinia  1  1/147 (0.68%)  0/123 (0.00%) 
Gastrointestinal viral infection  1  1/147 (0.68%)  0/123 (0.00%) 
Herpes zoster  1  1/147 (0.68%)  1/123 (0.81%) 
Impetigo  1  1/147 (0.68%)  0/123 (0.00%) 
Infected bites  1  0/147 (0.00%)  1/123 (0.81%) 
Influenza  1  0/147 (0.00%)  1/123 (0.81%) 
Lower respiratory tract infection  1  1/147 (0.68%)  0/123 (0.00%) 
Lymph node abscess  1  0/147 (0.00%)  1/123 (0.81%) 
Lymphangitis  1  0/147 (0.00%)  1/123 (0.81%) 
Meningitis viral  1  1/147 (0.68%)  0/123 (0.00%) 
Otitis media acute  1  0/147 (0.00%)  1/123 (0.81%) 
Parvovirus infection  1  1/147 (0.68%)  0/123 (0.00%) 
Peritonitis  1  1/147 (0.68%)  0/123 (0.00%) 
Pharyngitis streptococcal  1  1/147 (0.68%)  0/123 (0.00%) 
Pneumonia  1  2/147 (1.36%)  3/123 (2.44%) 
Pneumonia bacterial  1  1/147 (0.68%)  0/123 (0.00%) 
Pseudocroup  1  1/147 (0.68%)  0/123 (0.00%) 
Salmonella sepsis  1  0/147 (0.00%)  1/123 (0.81%) 
Scarlet fever  1  1/147 (0.68%)  1/123 (0.81%) 
Sepsis  1  0/147 (0.00%)  1/123 (0.81%) 
Septic shock  1  1/147 (0.68%)  0/123 (0.00%) 
Sinusitis  1  1/147 (0.68%)  0/123 (0.00%) 
Staphylococcal sepsis  1  0/147 (0.00%)  1/123 (0.81%) 
Subcutaneous abscess  1  2/147 (1.36%)  0/123 (0.00%) 
Tonsillitis streptococcal  1  2/147 (1.36%)  0/123 (0.00%) 
Toxoplasmosis  1  1/147 (0.68%)  0/123 (0.00%) 
Varicella  1  3/147 (2.04%)  1/123 (0.81%) 
Viral upper respiratory tract infection  1  1/147 (0.68%)  0/123 (0.00%) 
Wound infection  1  1/147 (0.68%)  0/123 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/147 (0.00%)  1/123 (0.81%) 
Arteriovenous fistula site complication  1  0/147 (0.00%)  1/123 (0.81%) 
Fibula fracture  1  0/147 (0.00%)  1/123 (0.81%) 
Post procedural haemorrhage  1  0/147 (0.00%)  1/123 (0.81%) 
Road traffic accident  1  1/147 (0.68%)  0/123 (0.00%) 
Transfusion-related acute lung injury  1  1/147 (0.68%)  0/123 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/147 (0.00%)  1/123 (0.81%) 
Aspartate aminotransferase increased  1  0/147 (0.00%)  1/123 (0.81%) 
C-reactive protein increased  1  1/147 (0.68%)  0/123 (0.00%) 
Hepatic enzyme increased  1  1/147 (0.68%)  1/123 (0.81%) 
Liver function test abnormal  1  1/147 (0.68%)  0/123 (0.00%) 
Serum ferritin increased  1  1/147 (0.68%)  0/123 (0.00%) 
Transaminases increased  1  0/147 (0.00%)  1/123 (0.81%) 
Weight decreased  1  1/147 (0.68%)  0/123 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/147 (0.68%)  1/123 (0.81%) 
Intervertebral disc compression  1  0/147 (0.00%)  1/123 (0.81%) 
Juvenile idiopathic arthritis  1  14/147 (9.52%)  13/123 (10.57%) 
Musculoskeletal chest pain  1  2/147 (1.36%)  0/123 (0.00%) 
Musculoskeletal disorder  1  1/147 (0.68%)  0/123 (0.00%) 
Osteoarthritis  1  1/147 (0.68%)  0/123 (0.00%) 
Osteonecrosis  1  0/147 (0.00%)  1/123 (0.81%) 
Osteoporosis  1  1/147 (0.68%)  0/123 (0.00%) 
Polyarthritis  1  0/147 (0.00%)  2/123 (1.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anaplastic large cell lymphoma T- and null-cell types  1  0/147 (0.00%)  1/123 (0.81%) 
Nervous system disorders     
Convulsion  1  0/147 (0.00%)  1/123 (0.81%) 
Migraine  1  1/147 (0.68%)  0/123 (0.00%) 
Nervous system disorder  1  0/147 (0.00%)  1/123 (0.81%) 
Paraesthesia  1  1/147 (0.68%)  0/123 (0.00%) 
Superior sagittal sinus thrombosis  1  1/147 (0.68%)  0/123 (0.00%) 
Psychiatric disorders     
Abnormal behaviour  1  1/147 (0.68%)  0/123 (0.00%) 
Suicide attempt  1  1/147 (0.68%)  0/123 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/147 (0.68%)  0/123 (0.00%) 
Reproductive system and breast disorders     
Vulvovaginal pain  1  0/147 (0.00%)  1/123 (0.81%) 
Vulvovaginal pruritus  1  0/147 (0.00%)  1/123 (0.81%) 
Respiratory, thoracic and mediastinal disorders     
Acute interstitial pneumonitis  1  1/147 (0.68%)  0/123 (0.00%) 
Cough  1  1/147 (0.68%)  0/123 (0.00%) 
Dyspnoea  1  1/147 (0.68%)  0/123 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  1/147 (0.68%)  2/123 (1.63%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/147 (0.68%)  0/123 (0.00%) 
Eczema  1  1/147 (0.68%)  0/123 (0.00%) 
Henoch-Schonlein purpura  1  0/147 (0.00%)  1/123 (0.81%) 
Ingrowing nail  1  1/147 (0.68%)  0/123 (0.00%) 
Rash  1  2/147 (1.36%)  1/123 (0.81%) 
Toxic skin eruption  1  1/147 (0.68%)  0/123 (0.00%) 
Urticaria  1  0/147 (0.00%)  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACZ885 Treated ACZ885 Treatment Naive
Affected / at Risk (%) Affected / at Risk (%)
Total   124/147 (84.35%)   91/123 (73.98%) 
Ear and labyrinth disorders     
Ear pain  1  10/147 (6.80%)  7/123 (5.69%) 
Gastrointestinal disorders     
Abdominal pain  1  21/147 (14.29%)  22/123 (17.89%) 
Abdominal pain upper  1  18/147 (12.24%)  13/123 (10.57%) 
Diarrhoea  1  30/147 (20.41%)  16/123 (13.01%) 
Nausea  1  17/147 (11.56%)  11/123 (8.94%) 
Vomiting  1  35/147 (23.81%)  18/123 (14.63%) 
General disorders     
Fatigue  1  10/147 (6.80%)  3/123 (2.44%) 
Pyrexia  1  38/147 (25.85%)  27/123 (21.95%) 
Infections and infestations     
Bronchitis  1  13/147 (8.84%)  6/123 (4.88%) 
Conjunctivitis  1  8/147 (5.44%)  6/123 (4.88%) 
Gastroenteritis  1  28/147 (19.05%)  19/123 (15.45%) 
Influenza  1  14/147 (9.52%)  4/123 (3.25%) 
Nasopharyngitis  1  47/147 (31.97%)  32/123 (26.02%) 
Oral herpes  1  11/147 (7.48%)  1/123 (0.81%) 
Otitis media  1  11/147 (7.48%)  7/123 (5.69%) 
Pharyngitis  1  15/147 (10.20%)  15/123 (12.20%) 
Respiratory tract infection  1  7/147 (4.76%)  13/123 (10.57%) 
Rhinitis  1  35/147 (23.81%)  26/123 (21.14%) 
Tonsillitis  1  10/147 (6.80%)  7/123 (5.69%) 
Upper respiratory tract infection  1  36/147 (24.49%)  24/123 (19.51%) 
Urinary tract infection  1  8/147 (5.44%)  4/123 (3.25%) 
Viral infection  1  6/147 (4.08%)  11/123 (8.94%) 
Viral upper respiratory tract infection  1  10/147 (6.80%)  4/123 (3.25%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  9/147 (6.12%)  12/123 (9.76%) 
Contusion  1  11/147 (7.48%)  0/123 (0.00%) 
Fall  1  11/147 (7.48%)  7/123 (5.69%) 
Ligament sprain  1  11/147 (7.48%)  5/123 (4.07%) 
Investigations     
Alanine aminotransferase increased  1  8/147 (5.44%)  5/123 (4.07%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  36/147 (24.49%)  25/123 (20.33%) 
Arthritis  1  9/147 (6.12%)  7/123 (5.69%) 
Back pain  1  11/147 (7.48%)  9/123 (7.32%) 
Joint swelling  1  9/147 (6.12%)  5/123 (4.07%) 
Juvenile idiopathic arthritis  1  23/147 (15.65%)  27/123 (21.95%) 
Myalgia  1  9/147 (6.12%)  6/123 (4.88%) 
Neck pain  1  8/147 (5.44%)  7/123 (5.69%) 
Pain in extremity  1  19/147 (12.93%)  12/123 (9.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  14/147 (9.52%)  4/123 (3.25%) 
Nervous system disorders     
Headache  1  30/147 (20.41%)  24/123 (19.51%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  37/147 (25.17%)  28/123 (22.76%) 
Epistaxis  1  10/147 (6.80%)  5/123 (4.07%) 
Oropharyngeal pain  1  36/147 (24.49%)  17/123 (13.82%) 
Skin and subcutaneous tissue disorders     
Eczema  1  12/147 (8.16%)  16/123 (13.01%) 
Rash  1  15/147 (10.20%)  13/123 (10.57%) 
Urticaria  1  7/147 (4.76%)  7/123 (5.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (i.e, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862­-778­-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00891046     History of Changes
Other Study ID Numbers: CACZ885G2301E1
EudraCT: 2008-008008-42
First Submitted: April 29, 2009
First Posted: April 30, 2009
Results First Submitted: October 13, 2015
Results First Posted: March 10, 2017
Last Update Posted: March 26, 2019