We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01242813
Recruitment Status : Completed
First Posted : November 17, 2010
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition TNF-receptor Associated Periodic Syndromes (TRAPS)
Intervention Drug: ACZ885
Enrollment 20
Recruitment Details The study was conducted at 6 centers in 3 countries.
Pre-assignment Details A total of 29 participants were screened, out of which 20 were enrolled and exposed to study medication. Nine participants were considered as screening failures due to unacceptable laboratory value or test procedure results.
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
The analysis was performed on Safety Set (SAF) defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
34.62  (18.362)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants
Ireland 2
Italy 10
United Kingdom 8
1.Primary Outcome
Title Percentage of Participants With Complete or Almost Complete Response at Day 15
Hide Description Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than [≥] 70% reduction of baseline CRP and/or SAA).
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95
(75.1 to 99.9)
2.Secondary Outcome
Title Percentage of Participants With Complete or Almost Complete Response at Day 8
Hide Description Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA < 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).
Time Frame Day 8
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80
(56.3 to 94.3)
3.Secondary Outcome
Title Percentage of Participants With Complete Clinical Remission at Day 8 and 15
Hide Description Complete clinical remission was defined as Physician's Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Day 8 and Day 15
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 8
90
(68.3 to 98.8)
Day 15
100
(83.2 to 100)
4.Secondary Outcome
Title Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15
Hide Description The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.
Time Frame Day 8 and Day 15
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 8
35
(15.4 to 59.2)
Day 15
60
(36.1 to 80.9)
5.Secondary Outcome
Title Time to Physician's Assessed Clinical Remission
Hide Description Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician's Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline up to Day 15
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Days
4
(3 to 8)
6.Secondary Outcome
Title Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8
Hide Description Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician's Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA < 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(39.8 to 100)
7.Secondary Outcome
Title Time to Participant's Assessed Clinical Remission
Hide Description Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Baseline up to Day 15
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Days
3
(1 to 11)
8.Secondary Outcome
Title Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study
Hide Description The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.
Time Frame Day 1 up to Day 953 (End of study)
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: Percent change
CRP
-92.19
(-99 to 43.6)
SAA
-96.54
(-99.8 to 68.3)
9.Secondary Outcome
Title Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Hide Description TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician's global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Day 113 (end of treatment period) up to Day 925 (End of study)
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Percentage of participants
Skin rash absent 95
Skin rash minimal 5
Skin rash mild 0
Skin rash moderate 0
Skin rash severe 0
Eye manifestations absent 90
Eye manifestations minimal 10
Eye manifestations mild 0
Eye manifestations moderate 0
Eye manifestations severe 0
Extremity pain absent 90
Extremity pain minimal 5
Extremity pain mild 5
Extremity pain moderate 0
Extremity pain severe 0
Abdominal pain absent 95
Abdominal pain minimal 5
Abdominal pain mild 0
Abdominal pain moderate 0
Abdominal pain severe 0
10.Secondary Outcome
Title Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Hide Description Participants were assessed based by physician on Physician's Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Day 1 up to Day 953 (End of study)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Percentage of participants
None 84.2
Minimal 10.5
Mild 0
Moderate 0
Severe 0
11.Secondary Outcome
Title Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Hide Description Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame Day 1 up to Day 253 (End of follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of participants
Absent 41.7
Minimal 33.3
Mild 8.3
Moderate 16.7
Severe 0
12.Secondary Outcome
Title Percentage of Relapsed Participants
Hide Description Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.
Time Frame Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 15
0 [1] 
(NA to NA)
Day 29
0 [1] 
(NA to NA)
Day 57
0 [1] 
(NA to NA)
Day 85
5
(0.1 to 24.9)
Day 113
0 [2] 
(NA to NA)
Day 141
10
(1.3 to 33.1)
Day 169
10
(1.9 to 45.5)
Day 197
35
(30.8 to 89.1)
Day 225
10
(6.8 to 93.2)
Day 253
10
(1.2 to 31.7)
Day 281
0 [1] 
(NA to NA)
Day 309
10
(1.2 to 31.7)
Day 337
5
(0.1 to 24.9)
Day 365
0 [1] 
(NA to NA)
Day 393
0 [1] 
(NA to NA)
Day 421
5
(0.1 to 27.3)
Day 449
0 [1] 
(NA to NA)
Day 477
5
(0.1 to 26.0)
Day 505
0 [1] 
(NA to NA)
Day 533
0 [1] 
(NA to NA)
Day 561
0 [1] 
(NA to NA)
Day 589
0 [1] 
(NA to NA)
Day 617
0 [1] 
(NA to NA)
Day 645
5
(0.5 to 71.6)
Day 673
15
(3.6 to 41.4)
Day 701
0 [1] 
(NA to NA)
Day 729
5
(0.1 to 27.3)
Day 757
0 [1] 
(NA to NA)
Day 785
0 [1] 
(NA to NA)
Day 813
0 [1] 
(NA to NA)
Day 841
10
(1.4 to 34.7)
Day 869
0 [1] 
(NA to NA)
Day 897
10
(1.4 to 34.7)
Day 925
0 [1] 
(NA to NA)
End of Study (Day 953)
0 [1] 
(NA to NA)
[1]
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
[2]
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable..
13.Secondary Outcome
Title Time to Relapse After Last Dose of Canakinumab
Hide Description Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.
Time Frame Day 85 to Day 253 (End of treatment period to Follow-up period)
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Days
91.5
(65 to 117)
14.Secondary Outcome
Title Percentage of Participants Who Relapsed and Received Rescue Medication
Hide Description Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.
Time Frame Day 85 to Day 953 (End of treatment period to End of study)
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Corticosteroid
25
(8.7 to 49.1)
NSAID
25
(8.7 to 49.1)
Both corticosteroid and NSAID
10
(1.2 to 31.7)
15.Secondary Outcome
Title Serum Concentration of Canakinumab
Hide Description Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.
Time Frame Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: microgram(s)/milliliter
Day 3 (n=20) 12.737  (5.3158)
Day 8 (n=19) 13.874  (4.5851)
Day 15 (n=19) 13.609  (5.5868)
Day 29 (n=20) 9.911  (4.2272)
Day 57 (n=20) 13.605  (5.4975)
Day 85 (n=20) 15.291  (6.4353)
Day 113 (n=20) 15.837  (6.828)
Day 141 (n=17) 8.799  (3.1486)
Day 169 (n=12) 5.655  (2.2158)
Day 197 (n=8) 3.906  (1.6446)
Day 225 (n=2) 2.725  (1.2799)
Day 253 (n=9) 10.261  (7.9592)
Day 281 (n=20) 9.759  (4.6194)
Day 309 (n=13) 13.088  (4.6648)
Day 337 (n=11) 13.182  (5.464)
Day 365 (n=9) 15.531  (6.7944)
Day 393 (n=2) 20.95  (1.6263)
Day 421 (n=2) 20.9  (2.9698)
Day 449 (n=17) 17.319  (6.496)
Day 533 (n=1) 18.4 [1]   (NA)
Day 561 (n=4) 15.55  (2.2128)
Day 589 (n=5) 16.48  (3.8134)
Day 617 (n=17) 14.124  (5.8931)
Day 645 (n=1) 7.45 [1]   (NA)
Day 673 (n=5) 9.802  (4.6757)
Day 729 (n=5) 8.912  (3.4413)
Day 785 (n=18) 7.757  (2.2948)
Day 841 (n=4) 8.528  (2.112)
Day 897 (n=9) 8.157  (2.6782)
Day 925 (n=3) 10.527  (7.4405)
Day 953 (n=10) 9.56  (2.9375)
[1]
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
16.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 competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).
Time Frame Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 3 (n=20) 12.616  (20.441)
Day 8 (n=19) 16.811  (20.237)
Day 15 (n=19) 10.662  (7.6915)
Day 29 (n=20) 9.342  (5.1266)
Day 57 (n=20) 10.701  (4.5329)
Day 85 (n=20) 11.212  (4.1552)
Day 113 (n=20) 14.401  (5.491)
Day 141 (n=17) 10.779  (4.1092)
Day 169 (n=12) 10.912  (8.2431)
Day 197 (n=8) 30.098  (41.158)
Day 225 (n=2) 3.52  (0.9475)
Day 253 (n=9) 25.002  (28.274)
Day 281 (n=20) 13.722  (7.5574)
Day 309 (n=13) 22.478  (16.688)
Day 337 (n=11) 19.904  (10.789)
Day 365 (n=9) 16.338  (5.8318)
Day 393 (n=2) 27.6  (10.182)
Day 421 (n=2) 30.65  (12.94)
Day 449 (n=17) 17.723  (8.8367)
Day 533 (n=1) 25.2 [1]   (NA)
Day 561 (n=4) 15.008  (5.4952)
Day 589 (n=5) 16.99  (5.2212)
Day 617 (n=17) 14.34  (6.1663)
Day 645 (n=1) 16 [1]   (NA)
Day 673 (n=5) 15.296  (11.908)
Day 729 (n=5) 16.702  (12.386)
Day 785 (n=18) 12.698  (6.0688)
Day 841 (n=4) 12.478  (6.9548)
Day 897 (n=9) 12.331  (8.032)
Day 925 (n=3) 15.033  (1.7502)
Day 953 (n=10) 11.701  (7.9172)
[1]
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
17.Secondary Outcome
Title Number of Participants With Anti-canakinumab Antibodies at Any Visit
Hide Description Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.
Time Frame Day 1 up to Day 953 (End of study)
Hide 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 (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Number of participants
2
Time Frame Day 1 up to Day 953 (End of study)
Adverse Event Reporting Description The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
 
Arm/Group Title Canakinumab
Hide Arm/Group Description Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
All-Cause Mortality
Canakinumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Canakinumab
Affected / at Risk (%)
Total   7/20 (35.00%) 
Cardiac disorders   
Pericarditis † 1  1/20 (5.00%) 
Gastrointestinal disorders   
Abdominal pain † 1  2/20 (10.00%) 
Diarrhoea † 1  1/20 (5.00%) 
Intestinal obstruction † 1  1/20 (5.00%) 
Vomiting † 1  1/20 (5.00%) 
General disorders   
Condition aggravated † 1  1/20 (5.00%) 
Infections and infestations   
Upper respiratory tract infection † 1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Meniscus injury † 1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hyperkalaemia † 1  1/20 (5.00%) 
Hypertriglyceridaemia † 1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Foot deformity † 1  1/20 (5.00%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy † 1  1/20 (5.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Canakinumab
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  2/20 (10.00%) 
Lymphadenopathy † 1  2/20 (10.00%) 
Cardiac disorders   
Tachycardia † 1  1/20 (5.00%) 
Ear and labyrinth disorders   
Deafness † 1  1/20 (5.00%) 
Ear pain † 1  3/20 (15.00%) 
Eye disorders   
Chalazion † 1  1/20 (5.00%) 
Conjunctival haemorrhage † 1  1/20 (5.00%) 
Conjunctivitis allergic † 1  1/20 (5.00%) 
Dry eye † 1  1/20 (5.00%) 
Eye pain † 1  1/20 (5.00%) 
Eye pruritus † 1  2/20 (10.00%) 
Eye swelling † 1  1/20 (5.00%) 
Eyelid oedema † 1  1/20 (5.00%) 
Ocular hyperaemia † 1  1/20 (5.00%) 
Periorbital oedema † 1  1/20 (5.00%) 
Gastrointestinal disorders   
Abdominal distension † 1  1/20 (5.00%) 
Abdominal pain † 1  11/20 (55.00%) 
Abdominal pain upper † 1  4/20 (20.00%) 
Constipation † 1  2/20 (10.00%) 
Dental caries † 1  1/20 (5.00%) 
Diarrhoea † 1  8/20 (40.00%) 
Dyspepsia † 1  2/20 (10.00%) 
Haematochezia † 1  1/20 (5.00%) 
Haemorrhoids † 1  1/20 (5.00%) 
Mouth ulceration † 1  1/20 (5.00%) 
Nausea † 1  2/20 (10.00%) 
Toothache † 1  3/20 (15.00%) 
Vomiting † 1  7/20 (35.00%) 
General disorders   
Asthenia † 1  1/20 (5.00%) 
Chest pain † 1  3/20 (15.00%) 
Condition aggravated † 1  3/20 (15.00%) 
Fatigue † 1  7/20 (35.00%) 
Non-cardiac chest pain † 1  2/20 (10.00%) 
Oedema peripheral † 1  1/20 (5.00%) 
Pyrexia † 1  10/20 (50.00%) 
Immune system disorders   
Seasonal allergy † 1  1/20 (5.00%) 
Infections and infestations   
Bronchitis † 1  4/20 (20.00%) 
Cystitis † 1  3/20 (15.00%) 
Ear infection † 1  1/20 (5.00%) 
Enterobiasis † 1  1/20 (5.00%) 
Fungal skin infection † 1  2/20 (10.00%) 
Gingivitis † 1  2/20 (10.00%) 
Haemorrhoid infection † 1  1/20 (5.00%) 
Hand-foot-and-mouth disease † 1  1/20 (5.00%) 
Influenza † 1  2/20 (10.00%) 
Laryngitis † 1  1/20 (5.00%) 
Lower respiratory tract infection † 1  3/20 (15.00%) 
Nasopharyngitis † 1  12/20 (60.00%) 
Onychomycosis † 1  1/20 (5.00%) 
Oral candidiasis † 1  1/20 (5.00%) 
Oral herpes † 1  1/20 (5.00%) 
Pharyngitis † 1  4/20 (20.00%) 
Pharyngitis streptococcal † 1  1/20 (5.00%) 
Pharyngotonsillitis † 1  1/20 (5.00%) 
Respiratory tract infection † 1  3/20 (15.00%) 
Rhinitis † 1  5/20 (25.00%) 
Sinusitis † 1  1/20 (5.00%) 
Tinea infection † 1  1/20 (5.00%) 
Tonsillitis † 1  1/20 (5.00%) 
Tooth abscess † 1  1/20 (5.00%) 
Tooth infection † 1  1/20 (5.00%) 
Upper respiratory tract infection † 1  6/20 (30.00%) 
Urinary tract infection † 1  1/20 (5.00%) 
Urinary tract infection viral † 1  2/20 (10.00%) 
Viral infection † 1  3/20 (15.00%) 
Viral upper respiratory tract infection † 1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Arthropod bite † 1  1/20 (5.00%) 
Contusion † 1  1/20 (5.00%) 
Joint dislocation † 1  1/20 (5.00%) 
Laceration † 1  1/20 (5.00%) 
Muscle rupture † 1  1/20 (5.00%) 
Muscle strain † 1  1/20 (5.00%) 
Skeletal injury † 1  1/20 (5.00%) 
Sunburn † 1  1/20 (5.00%) 
Investigations   
Blood creatinine increased † 1  2/20 (10.00%) 
Blood iron decreased † 1  1/20 (5.00%) 
Blood triglycerides increased † 1  1/20 (5.00%) 
Occult blood positive † 1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hyperkalaemia † 1  1/20 (5.00%) 
Hypertriglyceridaemia † 1  1/20 (5.00%) 
Iron deficiency † 1  1/20 (5.00%) 
Metabolic acidosis † 1  1/20 (5.00%) 
Vitamin D deficiency † 1  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  8/20 (40.00%) 
Back pain † 1  3/20 (15.00%) 
Flank pain † 1  2/20 (10.00%) 
Muscle spasms † 1  2/20 (10.00%) 
Musculoskeletal pain † 1  6/20 (30.00%) 
Myalgia † 1  6/20 (30.00%) 
Neck pain † 1  1/20 (5.00%) 
Osteoporosis † 1  1/20 (5.00%) 
Pain in extremity † 1  3/20 (15.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma † 1  2/20 (10.00%) 
Nervous system disorders   
Dizziness † 1  5/20 (25.00%) 
Dysgeusia † 1  1/20 (5.00%) 
Headache † 1  11/20 (55.00%) 
Hypoaesthesia † 1  1/20 (5.00%) 
Paraesthesia † 1  3/20 (15.00%) 
Presyncope † 1  1/20 (5.00%) 
Sinus headache † 1  1/20 (5.00%) 
Syncope † 1  1/20 (5.00%) 
Tremor † 1  1/20 (5.00%) 
Psychiatric disorders   
Depression † 1  2/20 (10.00%) 
Renal and urinary disorders   
Dysuria † 1  1/20 (5.00%) 
Polyuria † 1  1/20 (5.00%) 
Strangury † 1  1/20 (5.00%) 
Reproductive system and breast disorders   
Breast cyst † 1  1/20 (5.00%) 
Breast mass † 1  1/20 (5.00%) 
Dysmenorrhoea † 1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  6/20 (30.00%) 
Dysphonia † 1  1/20 (5.00%) 
Dyspnoea † 1  2/20 (10.00%) 
Epistaxis † 1  3/20 (15.00%) 
Nasal congestion † 1  1/20 (5.00%) 
Oropharyngeal pain † 1  11/20 (55.00%) 
Rhinitis allergic † 1  1/20 (5.00%) 
Rhinorrhoea † 1  2/20 (10.00%) 
Sneezing † 1  1/20 (5.00%) 
Tonsillar hypertrophy † 1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Acne † 1  1/20 (5.00%) 
Actinic keratosis † 1  1/20 (5.00%) 
Alopecia † 1  1/20 (5.00%) 
Dermal cyst † 1  1/20 (5.00%) 
Dry skin † 1  1/20 (5.00%) 
Hyperhidrosis † 1  1/20 (5.00%) 
Ingrown hair † 1  1/20 (5.00%) 
Rash † 1  3/20 (15.00%) 
Rash erythematous † 1  1/20 (5.00%) 
Skin discolouration † 1  1/20 (5.00%) 
Urticaria † 1  2/20 (10.00%) 
Surgical and medical procedures   
Nasal septal operation † 1  1/20 (5.00%) 
Skin neoplasm excision † 1  1/20 (5.00%) 
Tooth extraction † 1  1/20 (5.00%) 
Vascular disorders   
Hypertension † 1  2/20 (10.00%) 
Phlebitis † 1  1/20 (5.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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 (ie, 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01242813    
Other Study ID Numbers: CACZ885D2203
2010-020061-24
First Submitted: November 16, 2010
First Posted: November 17, 2010
Results First Submitted: November 2, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016