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Canakinumab in Patients With Active Hyper-IgD Syndrome

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ClinicalTrials.gov Identifier: NCT01303380
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : August 19, 2015
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mevalonate Kinase Deficiency
Intervention Drug: Canakinumab
Enrollment 9
Recruitment Details The study was conducted at 3 centres in Spain.
Pre-assignment Details A total of 10 participants were screened, 9 of which entered in the treatment period of the study, one participant was considered to be a screening failure.
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Lack of compliance to study procedures             1
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
The analysis was performed in the Full Analysis Set (FAS), defined as all participants who received at least one application of study treatment and had at least one post-baseline assessment for primary efficacy variable.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
17.3
(5 to 29)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
Children (2­-11 years) 3
Adolescents (12­-17 years) 3
Adults (18-­64 years) 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 9 participants
9
1.Primary Outcome
Title Number of Flares Per Participant During Historical Period and Treatment Period
Hide Description A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a C­reactive protein (CRP) value > 10 mg/L. Flares during a historical period were defined as most recent 6-months in which the participant has not received treatment for their HIDS other than symptomatic treatment with NSAIDs and/or corticosteroids.
Time Frame Historical period, Month 6 (End of treatment period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed in the Full Analysis set (FAS) population defined as all participants who received at least one dose of study treatment and had at least one post baseline assessment.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Number of flares
Historical period
5
(3 to 12)
Month 6
0
(0 to 2)
2.Secondary Outcome
Title Number of Flares Per Participant at During Treatment Period and 24 Month Extension Period
Hide Description A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.
Time Frame Month 6 (End of treatment period), Month 36 (End of Long term treatment Period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Number of flares
Treatment period
0
(0 to 2)
Long term treatment period
0
(0 to 1)
3.Secondary Outcome
Title Number of Participants Who Flared at Month 6, Month 24 and Month 36
Hide Description A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.
Time Frame Baseline, Month 6 (End of treatment period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Number of participants
Treatment period 2
End of Long term treatment Period 1 4
End of Long term treatment Period 2 2
4.Secondary Outcome
Title Number of Participants With Flare Events Based on Physician Assessed HIDS Flare Severity Score
Hide Description Physician global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5­ point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe.
Time Frame Any flare event [Baseline up to Month 36 (End of long term treatment period 2)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Number of participants
Day 45, Absent (n=9) 0
Day 45, Minimal (n=9) 0
Day 45,Mild (n=9) 0
Day 45,Moderate (n=9) 1
Day 45,Severe (n=9) 0
Flare/Unscheduled visit 1, Absent (n=2) 2
Flare/Unscheduled visit 1, Minimal (n=2) 0
Flare/Unscheduled visit 1, Mild (n=2) 1
Flare/Unscheduled visit 1, Moderated (n=2) 1
Flare/Unscheduled visit 1, Severe (n=2) 0
Flare/Unscheduled visit 2, Absent (n=2) 1
Flare/Unscheduled visit 2, Minimal (n=2) 0
Flare/Unscheduled visit 2, Mild (n=2) 1
Flare/Unscheduled visit 2, Moderate (n=2) 0
Flare/Unscheduled visit 2, Severe (n=2) 0
Flare/Unscheduled visit 3, Absent (n=2) 1
Flare/Unscheduled visit 3, Minimal (n=2) 0
Flare/Unscheduled visit 3, Mild (n=2) 0
Flare/Unscheduled visit 3, Moderate (n=2) 1
Flare/Unscheduled visit 3, Severe (n=2) 0
End of Treatment period, Absent (n=7) 0
End of Treatment period, Minimal (n=7) 0
End of Treatment period, Mild (n=7) 4
End of Treatment period, Moderate (n=7) 3
End of Treatment period, Severe (n=7) 0
End of Follow­up period, Absent (n=8) 0
End of Follow­up period, Minimal (n=8) 1
End of Follow­up period, Mild (n=8) 0
End of Follow­up period, Moderate (n=8) 0
End of Follow­up period, Severe (n=8) 0
Long term period 1, Flare 1, Absent (n=3) 0
Long term period 1, Flare 1, Minimal (n=3) 1
Long term period 1, Flare 1, Mild (n=3) 1
Long­term 12 M period, Flare 1, Moderate (n=3) 1
Long­term 12 M period, Flare 1, Severe (n=3) 0
Long term period 1, Flare 2, Absent (n=1) 0
Long­term 12 M period, Flare 2, Minimal (n=1) 0
Long­term 12 M period, Flare 2, Mild (n=1) 1
Long term period 1, Flare 2, Moderate (n=1) 0
Long term period 1, Flare 2, Severe (n=1) 0
Long term period 1, Flare 3, Absent (n=1) 0
Long term period 1, Flare 3, Minimal (n=1) 0
Long term period 1, Flare 3, Mild (n=1) 1
Long term period 1, Flare 3, Moderate (n=1) 0
Long term period 1, Flare 3, Severe (n=1) 0
Long term period 2, Absent (n=2) 1
Long term period 2, Minimal (n=2) 0
Long term period 2, Mild (n=2) 1
Long term period 2, Moderate (n=2) 0
Long term period 2, Severe (n=2) 0
5.Secondary Outcome
Title Number of Participants With Flare Events Based on Participant Assessed HIDS Flare Severity Score
Hide Description Participant's global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5-point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe. Same investigator assessed the same participant throughout the study to ensure consistency between assessments. Investigators reviewed every participant's diary at each visit after their own clinical assessment.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Number of participants
Treatment period, Absent 0
Treatment period, Minimal 0
Treatment period, Mild 1
Treatment period, Moderate 1
Treatment period, Severe 0
Follow-up period, Absent 0
Follow-up period, Minimal 0
Follow-up period, Mild 0
Follow-up period, Moderate 2
Follow-up period, Severe 0
Long term period 1, Absent 0
Long term period 1, Minimal 1
Long term period 1, Mild 1
Long term period 1, Moderate 2
Long term period 1, Severe 0
Long term period 2, Absent 0
Long term period 2, Minimal 1
Long term period 2, Mild 0
Long term period 2, Moderate 0
Long term period 2, Severe 0
6.Secondary Outcome
Title Percentage of Participants With Defined Grades of Participants Assessed Symptom Control
Hide Description Participants were assessed by participants/parent (participants aged 6-18 years) for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, No control (n=9) 0
Treatment period, Poor control (n=9) 0
Treatment period, Somewhat control (n=9) 11.11
Treatment period, Good control (n=9) 33.33
Treatment period, Excellent control (n=9) 55.56
Follow-up period, No control (n=9) 0
Follow-up period, Poor control (n=9) 0
Follow-up period, Somewhat control (n=9) 0
Follow-up period, Good control (n=9) 33.33
Follow-up period, Excellent control (n=9) 66.67
Long term period 1, No control (n=8) 0
Long term period 1, Poor control (n=8) 0
Long term period 1, Somewhat control (n=8) 12.5
Long term period 1, Good control (n=8) 25
Long term period 1, Excellent control (n=8) 62.5
Long term period 2, No control (n=8) 0
Long term period 2, Poor control (n=8) 0
Long term period 2, Somewhat control (n=8) 0
Long term period 2, Good control (n=8) 12.5
Long term period 2, Excellent control (n=8 87.5
7.Secondary Outcome
Title Percentage of Participants With Defined Grades of Physician Assessed Symptom Control
Hide Description Participants were assessed by physician for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, No control (n=9) 0
Treatment period, Poor control (n=9) 0
Treatment period, Somewhat control (n=9) 0
Treatment period, Good control (n=9) 44.44
Treatment period, Excellent control (n=9) 55.56
Follow-up period, No control (n=9) 0
Follow-up period, Poor control (n=9) 0
Follow-up period, Somewhat control (n=9) 0
Follow-up period, Good control (n=9) 33.33
Follow-up period, Excellent control (n=9) 66.67
Long term period 1, No control (n=8) 0
Long term period 1, Poor control (n=8) 0
Long term period 1, Somewhat control (n=8) 12.5
Long term period 1, Good control (n=8) 25
Long term period 1, Excellent control (n=8) 62.5
Long term period 2, No control (n=8) 0
Long term period 2, Poor control (n=8) 0
Long term period 2, Somewhat control (n=8) 0
Long term period 2, Good control (n=8) 0
Long term period 2, Excellent control (n=8 100
8.Secondary Outcome
Title Percentage of Participants Experiencing Fever as Assessed by Physician's Global Assessment
Hide Description Fever severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, Absent (n=9) 88.89
Treatment period, Minimal (n=9) 11.11
Treatment period, Mild (n=9) 0
Treatment period, Moderate (n=9) 0
Treatment period, Severe (n=9) 0
Follow-up period, Absent (n=9) 100
Follow-up period, Minimal (n=9) 0
Follow-up period, Mild (n=9) 0
Follow-up period, Moderate (n=9) 0
Follow-up period, Severe (n=9) 0
Long term period 1, Absent (n=8) 75
Long term period 1, Minimal (n=8) 12.5
Long term period 1, Mild (n=8) 12.5
Long term period 1, Moderate (n=8) 0
Long term period 1, Severe (n=8) 0
Long term period 2, Absent (n=8) 100
Long term period 2, Minimal (n=8) 0
Long term period 2, Mild (n=8) 0
Long term period 2, Moderate (n=8) 0
Long term period 2, Severe (n=8) 0
9.Secondary Outcome
Title Percentage of Participants Experiencing Apthus Ulcers as Assessed by Physician's Global Assessment
Hide Description Apthus ulcers were assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, Absent (n=9) 88.89
Treatment period, Minimal (n=9) 0
Treatment period, Mild (n=9) 11.11
Treatment period, Moderate (n=9) 0
Treatment period, Severe (n=9) 0
Follow-up period, Absent (n=9) 100
Follow-up period, Minimal (n=9) 0
Follow-up period, Mild (n=9) 0
Follow-up period, Moderate (n=9) 0
Follow-up period, Severe (n=9) 0
Long term period 1, Absent (n=8) 100
Long term period 1, Minimal (n=8) 0
Long term period 1, Mild (n=8) 0
Long term period 1, Moderate (n=8) 0
Long term period 1, Severe (n=8) 0
Long term period 2, Absent (n=8) 100
Long term period 2, Minimal (n=8) 0
Long term period 2, Mild (n=8) 0
Long term period 2, Moderate (n=8) 0
Long term period 2, Severe (n=8) 0
10.Secondary Outcome
Title Percentage of Participants Experiencing Lymphadenopathy as Assessed by Physician's Global Assessment
Hide Description Lymphadenopathy severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, Absent (n=9) 88.89
Treatment period, Minimal (n=9) 11.11
Treatment period, Mild (n=9) 0
Treatment period, Moderate (n=9) 0
Treatment period, Severe (n=9) 0
Follow-up period, Absent (n=9) 77.78
Follow-up period, Minimal (n=9) 22.22
Follow-up period, Mild (n=9) 0
Follow-up period, Moderate (n=9) 0
Follow-up period, Severe (n=9) 0
Long term period 1, Absent (n=8) 87.5
Long term period 1, Minimal (n=8) 12.5
Long term period 1, Mild (n=8) 0
Long term period 1, Moderate (n=8) 0
Long term period 1, Severe (n=8) 0
Long term period 2, Absent (n=8) 100
Long term period 2, Minimal (n=8) 0
Long term period 2, Mild (n=8) 0
Long term period 2, Moderate (n=8) 0
Long term period 2, Severe (n=8) 0
11.Secondary Outcome
Title Percentage of Participants Experiencing Abdominal Pain as Assessed by Physician's Global Assessment
Hide Description Abdominal pain was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment period, Absent (n=9) 100
Treatment period, Minimal (n=9) 0
Treatment period, Mild (n=9) 0
Treatment period, Moderate (n=9) 0
Treatment period, Severe (n=9) 0
Follow-up period, Absent (n=9) 100
Follow-up period, Minimal (n=9) 0
Follow-up period, Mild (n=9) 0
Follow-up period, Moderate (n=9) 0
Follow-up period, Severe (n=9) 0
Long term period 1, Absent (n=8) 87.5
Long term period 1, Minimal (n=8) 12.5
Long term period 1, Mild (n=8) 0
Long term period 1, Moderate (n=8) 0
Long term period 1, Severe (n=8) 0
Long term period 2, Absent (n=8) 100
Long term period 2, Minimal (n=8) 0
Long term period 2, Mild (n=8) 0
Long term period 2, Moderate (n=8) 0
Long term period 2, Severe (n=8) 0
12.Secondary Outcome
Title Time to Resolution of the Initial Flare After First Canakinumab Treatment
Hide Description Time to resolution of the initial flare after first dose of canakinumab was determined.
Time Frame Day 1 (Baseline), Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Days
3
(1 to 5)
13.Secondary Outcome
Title Change From Baseline in Inflammation Markers Over Time up to Month 24
Hide Description The C-reactive Protein (CRP) and/or Serum amyloid A protein (SAA) were used as inflammatory markers. The normal range of CRP was 0-10 mg/L.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
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Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: milligram(s)/liter
CRP- 6 month (Treatment period), (n=6)
-120.5
(-164 to -23)
CRP- 6 month (Follow-up period), (n=9)
-111
(-164 to -23)
CRP- Long term period 1, (n=8)
-113.55
(-159.5 to -49.9)
CRP- Long term period 2, (n=8)
-125.2
(-164 to -34.1)
SAA- 6 month (Treatment period), (n=1)
-624.2
(-624.2 to -23)
SAA- 6 month (Follow-up period), (n=2)
-685.95
(-748.2 to -623.7)
SAA- Long term period 1, (n=2)
-684.1
(-749.2 to -619)
SAA- Long term period 2, (n=2)
-686.7
(-747.7 to -625.7)
14.Secondary Outcome
Title Health Assessment Questionnaire (HAQ) Global Score in Adults Over Time
Hide Description Participants were assessed for health-related quality of life (HRQoL) based on Health Assessment Questionnaire (HAQ). HAQ was an eight 8 categories questionnaire representing all activities related to physical function. Each category has various sub-categories, which were rated by the participants on a 4- point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The total score was the mean of the 8 scores, and ranged from 0 (no disability) to 3 (completely disabled).
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
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Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here "Number of participants analyzed" signifies the participants assessed for HAQ during study.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Score on a scale
Treatment period, (n=3)
0
(0 to 0)
Follow-up period, (n=4)
0
(0 to 0)
Long term period 1, (n=5)
0
(0 to 1)
Long term period 2, (n=4)
0
(0 to 0)
15.Secondary Outcome
Title Childhood Health Assessment Questionnaire (CHAQ) Global Score in Children Over Time
Hide Description Participants or their parents (participants aged 6 to 17 years) were assessed for HRQoL based on Childhood Health Assessment Questionnaire (CHAQ). CHAQ was an eight domain questionnaire representing functional capacity and independence, evaluated for previous week. Each domain was rated on a 4-point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do.The total score is the mean from the 8 scores, and ranges from 0 (no disability) to 3 (completely disabled).
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
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Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here "Number of participants analyzed" signifies the participants assessed for CHAQ during study.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Score on a scale
End to treatment period (n= 2)
0
(0 to 0)
End to follow-up period (n=4)
0.1
(0 to 1)
Long term period 1, (n=2)
0.1
(0 to 1)
Long term period 2, (n=1)
0.1
(0 to 1)
16.Secondary Outcome
Title Percentage of Participants Who Received Dose Up-titration During 6-month Treatment Period
Hide Description Participants who experienced a new HIDS flare between baseline and Week 4 and received an escalated dose of 450 mg of canakinumab every 6 weeks thereafter starting at Week 6 were determined.
Time Frame Day 1 up to Month 6 (End of follow up)
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Hide Analysis Population Description
The analysis was performed in the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
22.22
17.Secondary Outcome
Title Duration of Flares Experienced During the Study
Hide Description Flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L. The change in post canakinumab treatment flare duration during the study were assessed as compared to historical period.
Time Frame Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)
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Hide Analysis Population Description
The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Days
Treatment period, (n=3)
3
(2 to 4)
Follow-up period, (n=7)
4
(2 to 10)
Long term period 1, (n=6)
3.5
(2 to 8)
Long term period 2, (n=2)
8.5
(6 to 11)
18.Secondary Outcome
Title Time to Flare After the Last Dose of Canakinumab During the Follow-up Period
Hide Description The median time to flare by the participants after administration of the last dose of canakinumab during the follow-up period was analysed using Kaplan-Meier method.
Time Frame Last dose of canakinumab treatment in follow-up period to end of follow-up period (Day 337)
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Hide Analysis Population Description
The analysis was performed on the FAS population. Here "Number of participants analysed" signifies the participants assessed for time to flare after the last dose of canakinumab during follow-up period.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: days
110
(62 to 196)
19.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Time Frame Day 1 (Start of study treatment) up to Month 36 (End of study)
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Hide Analysis Population Description
The analysis was performed on Safety Set (SAF) population defined as all participants who received at least one application of study treatment and had at least one post-baseline safety assessment.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Number of participants
Adverse events 9
Serious adverse events 4
20.Secondary Outcome
Title Participants Who Received Rescue Treatment
Hide Description Participants who experienced flares were treated with corticosteroids and NSAIDs as rescue medication.
Time Frame Baseline up to Month 36 (End of study)
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Hide Analysis Population Description
The analysis was performed on the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
11.11
21.Secondary Outcome
Title Serum Concentration-time Profile of Canakinumab
Hide Description Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics (PK) of the drug.
Time Frame Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)
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Hide Analysis Population Description
The analysis was performed on the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: microgram(s)/milliliter
Day 4 28.8  (7.9)
Day 15 26.9  (8)
Day 43 12.7  (4.6)
Day 85 19.4  (9.6)
Day 127 23.8  (12.8)
Day 169 24  (13.4)
Day 197 12.6  (13.7)
Day 225 11.5  (7.9)
Day 253 6.5  (4.8)
Day 281 1.6  (1.6)
Day 309 0.9  (1)
Day 337 32.6  (15.9)
22.Secondary Outcome
Title Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Hide Description Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of sandwich ELISA assay with limit of detection at 0.1 picogram/millilitre.
Time Frame Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: picogram(s)/milliliter
Day 4 27.3  (25.2)
Day 15 22.2  (14.7)
Day 43 21.8  (13.9)
Day 85 27.3  (14)
Day 127 24.3  (12.1)
Day 169 32.5  (17.9)
Day 197 16.3  (5.9)
Day 225 17  (8.3)
Day 253 10.2  (5.8)
Day 281 4.9  (3.3)
Day 309 3.7  (2)
Day 337 49.1  (60.2)
23.Secondary Outcome
Title Number of Participants Exhibiting Anti-canakinumab Antibodies at Any Visit
Hide Description Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using bridging ECLIA assay.
Time Frame Baseline up to Month 36 (End of study)
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Hide Analysis Population Description
The analysis was performed on the FAS population.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Number of participants
0
Time Frame Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV). All other adverse events are monitored from First Participant First Treatment until LPLV.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator’s discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
All-Cause Mortality
Canakinumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Canakinumab
Affected / at Risk (%)
Total   4/9 (44.44%) 
Blood and lymphatic system disorders   
Anaemia  1  1/9 (11.11%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/9 (11.11%) 
General disorders   
Disease progression  1  1/9 (11.11%) 
Infections and infestations   
Cellulitis  1  1/9 (11.11%) 
Peritonitis  1  1/9 (11.11%) 
Pneumonia  1  1/9 (11.11%) 
Streptococcal bacteraemia  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Fluid overload  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Temporomandibular joint syndrome  1  1/9 (11.11%) 
Nervous system disorders   
Headache  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Hidradenitis  1  1/9 (11.11%) 
Vascular disorders   
Hypertensive crisis  1  1/9 (11.11%) 
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%
Canakinumab
Affected / at Risk (%)
Total   9/9 (100.00%) 
Cardiac disorders   
Tachycardia  1  1/9 (11.11%) 
Eye disorders   
Conjunctival hyperaemia  1  1/9 (11.11%) 
Conjunctivitis  1  1/9 (11.11%) 
Gastrointestinal disorders   
Abdominal pain  1  2/9 (22.22%) 
Abdominal pain upper  1  1/9 (11.11%) 
Aphthous stomatitis  1  2/9 (22.22%) 
Diarrhoea  1  2/9 (22.22%) 
Dyspepsia  1  2/9 (22.22%) 
Toothache  1  1/9 (11.11%) 
Vomiting  1  2/9 (22.22%) 
General disorders   
Impaired healing  1  1/9 (11.11%) 
Influenza like illness  1  1/9 (11.11%) 
Pyrexia  1  4/9 (44.44%) 
Infections and infestations   
Bronchitis  1  1/9 (11.11%) 
Candidiasis  1  1/9 (11.11%) 
Cellulitis  1  1/9 (11.11%) 
Folliculitis  1  1/9 (11.11%) 
Impetigo  1  1/9 (11.11%) 
Infection  1  1/9 (11.11%) 
Influenza  1  1/9 (11.11%) 
Nasopharyngitis  1  1/9 (11.11%) 
Pharyngotonsillitis  1  3/9 (33.33%) 
Respiratory tract infection  1  2/9 (22.22%) 
Sinusitis  1  1/9 (11.11%) 
Tonsillitis  1  1/9 (11.11%) 
Tonsillitis streptococcal  1  1/9 (11.11%) 
Tooth infection  1  1/9 (11.11%) 
Upper respiratory tract infection  1  1/9 (11.11%) 
Urinary tract infection  1  2/9 (22.22%) 
Vulvovaginal mycotic infection  1  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Upper limb fracture  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/9 (22.22%) 
Back pain  1  1/9 (11.11%) 
Neck pain  1  2/9 (22.22%) 
Scoliosis  1  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bone neoplasm  1  1/9 (11.11%) 
Nervous system disorders   
Dizziness  1  1/9 (11.11%) 
Headache  1  1/9 (11.11%) 
Reproductive system and breast disorders   
Vaginal ulceration  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/9 (11.11%) 
Oropharyngeal pain  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/9 (11.11%) 
Eczema  1  1/9 (11.11%) 
Erythema nodosum  1  1/9 (11.11%) 
Hidradenitis  1  1/9 (11.11%) 
Surgical and medical procedures   
Tooth extraction  1  1/9 (11.11%) 
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
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 ­778 ­8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01303380     History of Changes
Other Study ID Numbers: CACZ885D2402
2010-020904-31 ( EudraCT Number )
First Submitted: February 23, 2011
First Posted: February 24, 2011
Results First Submitted: July 15, 2015
Results First Posted: August 19, 2015
Last Update Posted: November 5, 2015