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ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab (ß-SPECIFIC 4)

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: NCT02296424
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Juvenile Idiopathic Arthritis (SJIA)
Intervention Drug: ACZ885 150 mg (Canakinumab)
Enrollment 182
Recruitment Details 182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy
Pre-assignment Details 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
Arm/Group Title Cohort 1 PART 1: Cohort 2 Dose Reduction Dose Interval Prolongation
Hide Arm/Group Description Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II
Period Title: Part 1
Started 84 [1] 98 0 0
Completed 61 65 0 0
Not Completed 23 33 0 0
Reason Not Completed
New therapy for study indication             0             1             0             0
Protocol Violation             0             1             0             0
Withdrawal by Subject             0             2             0             0
Study terminated by sponsor             0             1             0             0
Adverse Event             2             11             0             0
Lack of Efficacy             5             17             0             0
16 directly started part II             16             0             0             0
[1]
16 patients immediately went into Part II
Period Title: Part 2
Started 0 0 38 37
Completed 0 0 35 37
Not Completed 0 0 3 0
Reason Not Completed
Lack of Efficacy             0             0             1             0
Adverse Event             0             0             1             0
Lost to Follow-up             0             0             1             0
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease

Dose interval prologation All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of this study

All participants in Part II of this study came from Part 1, So only Part 1 is shown here in Baseline Characteristics

Total of all reporting groups
Overall Number of Baseline Participants 68 98 166
Hide Baseline Analysis Population Description
Safety Set All patients who received at least one dose of study drug in Cohort 1 (resp. in Cohort 2) and had at least one post-treatment safety assessment in Part I before the canakinumab dose reduction/interval prolongation part. Of note, the statement that a patient had no adverse events (AE) also constituted a safety assessment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Age (years) Number Analyzed 68 participants 98 participants 166 participants
11.8  (4.53) 8.3  (4.20) 9.7  (4.66)
[1]
Measure Analysis Population Description: Safety Set
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
>=2 - <4 years Number Analyzed 1 participants 14 participants 15 participants
1 14 15
>=4 - <6 years Number Analyzed 6 participants 17 participants 23 participants
6 17 23
>=6 - <12 years Number Analyzed 24 participants 42 participants 66 participants
24 42 66
>=12 - <20 years Number Analyzed 34 participants 25 participants 59 participants
34 25 59
>=20 years Number Analyzed 3 participants 0 participants 3 participants
3 3
[1]
Measure Analysis Population Description: Safety Set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 98 participants 166 participants
Female
34
  50.0%
42
  42.9%
76
  45.8%
Male
34
  50.0%
56
  57.1%
90
  54.2%
[1]
Measure Analysis Population Description: Safety Set
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 98 participants 166 participants
American Indian or Alaska Native
0
   0.0%
1
   1.0%
1
   0.6%
Asian
0
   0.0%
2
   2.0%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.5%
1
   1.0%
2
   1.2%
White
66
  97.1%
81
  82.7%
147
  88.6%
More than one race
1
   1.5%
12
  12.2%
13
   7.8%
Unknown or Not Reported
0
   0.0%
1
   1.0%
1
   0.6%
1.Primary Outcome
Title Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval.
Hide Description

The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration.

In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward.

Time Frame baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Canakinumab Dose Reduction Canakinumab Dose Interval Prolongation
Hide Arm/Group Description:
Cohort 1 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
Cohort 2 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: particiapants
Able to remain on dose Number Analyzed 11 participants 6 participants
27 31
Not able to remain on dose Number Analyzed 38 participants 37 participants
11 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Canakinumab Dose Reduction, Canakinumab Dose Interval Prolongation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1
Hide Description AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)
Time Frame During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Canakinumab Dose Reduction Canakinumab Dose Interval Prolongation
Hide Arm/Group Description:
Cohort 1 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
Cohort 2 All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
Overall Number of Participants Analyzed 68 98
Measure Type: Number
Unit of Measure: number of participants
Number of patients with at least one AE 57 91
Number of patients with death 0 0
Number of patients with at least one SAE 10 23
3.Secondary Outcome
Title Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2
Hide Description AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)
Time Frame During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Canakinumab Dose Reduction Canakinumab Dose Interval Prolongation
Hide Arm/Group Description:
Cohort 1 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
Cohort 2 All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: number of participants
Number of patients with at least one AE 38 34
Number of patients with death 0 0
Number of patients with at least one SAE 4 1
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to estimated study duration of not more than 216 weeks (with an average duration of 108 weeks)
Adverse Event Reporting Description Arms/Groups are combined because a threshold of 5% indicates that all Other (Not Including Serious) Adverse Events with a frequency greater than 5% within at least one arm or comparison group are reported.
 
Arm/Group Title Part I Part II@Dose Reduction Part II@Dose Interval@Prolongation
Hide Arm/Group Description Part I Part II@Dose reduction Part II@Dose interval@prolongation
All-Cause Mortality
Part I Part II@Dose Reduction Part II@Dose Interval@Prolongation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)   0/38 (0.00%)   0/37 (0.00%) 
Hide Serious Adverse Events
Part I Part II@Dose Reduction Part II@Dose Interval@Prolongation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/166 (19.88%)   4/38 (10.53%)   1/37 (2.70%) 
Blood and lymphatic system disorders       
Histiocytosis haematophagic  1  3/166 (1.81%)  1/38 (2.63%)  1/37 (2.70%) 
Leukopenia  1  0/166 (0.00%)  0/38 (0.00%)  1/37 (2.70%) 
Lymphadenitis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Lymphadenopathy  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Cardiac disorders       
Pericarditis  1  2/166 (1.20%)  0/38 (0.00%)  0/37 (0.00%) 
Eye disorders       
Eye swelling  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Abdominal pain upper  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Diarrhoea  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Enteritis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
General disorders       
Pyrexia  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Infections and infestations       
Appendicitis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Atypical pneumonia  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Bronchitis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Gastroenteritis  1  2/166 (1.20%)  0/38 (0.00%)  0/37 (0.00%) 
Infectious mononucleosis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Influenza  1  0/166 (0.00%)  1/38 (2.63%)  0/37 (0.00%) 
Otitis media  1  1/166 (0.60%)  1/38 (2.63%)  0/37 (0.00%) 
Otitis media acute  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Pneumonia  1  2/166 (1.20%)  0/38 (0.00%)  0/37 (0.00%) 
Respiratory tract infection  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Viral infection  1  2/166 (1.20%)  0/38 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications       
Limb injury  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Thoracic vertebral fracture  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Juvenile idiopathic arthritis  1  8/166 (4.82%)  0/38 (0.00%)  0/37 (0.00%) 
Osteoarthritis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Osteonecrosis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Pain in extremity  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Still's disease  1  2/166 (1.20%)  0/38 (0.00%)  0/37 (0.00%) 
Nervous system disorders       
Idiopathic intracranial hypertension  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Alveolar proteinosis  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Interstitial lung disease  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Lichen planus  1  0/166 (0.00%)  1/38 (2.63%)  0/37 (0.00%) 
Rash pruritic  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
Rash scarlatiniform  1  1/166 (0.60%)  0/38 (0.00%)  0/37 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part I Part II@Dose Reduction Part II@Dose Interval@Prolongation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   140/166 (84.34%)   38/38 (100.00%)   34/37 (91.89%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  10/166 (6.02%)  1/38 (2.63%)  2/37 (5.41%) 
Leukopenia  1  7/166 (4.22%)  0/38 (0.00%)  2/37 (5.41%) 
Eye disorders       
Conjunctivitis allergic  1  2/166 (1.20%)  1/38 (2.63%)  2/37 (5.41%) 
Gastrointestinal disorders       
Abdominal pain  1  13/166 (7.83%)  5/38 (13.16%)  6/37 (16.22%) 
Abdominal pain upper  1  14/166 (8.43%)  2/38 (5.26%)  1/37 (2.70%) 
Diarrhoea  1  18/166 (10.84%)  4/38 (10.53%)  2/37 (5.41%) 
Nausea  1  11/166 (6.63%)  3/38 (7.89%)  3/37 (8.11%) 
Vomiting  1  17/166 (10.24%)  3/38 (7.89%)  0/37 (0.00%) 
Constipation  1  3/166 (1.81%)  4/38 (10.53%)  2/37 (5.41%) 
Gastritis  1  1/166 (0.60%)  2/38 (5.26%)  1/37 (2.70%) 
Odynophagia  1  0/166 (0.00%)  2/38 (5.26%)  0/37 (0.00%) 
Toothache  1  3/166 (1.81%)  2/38 (5.26%)  0/37 (0.00%) 
General disorders       
Injection site reaction  1  13/166 (7.83%)  2/38 (5.26%)  1/37 (2.70%) 
Pyrexia  1  33/166 (19.88%)  9/38 (23.68%)  12/37 (32.43%) 
Fatigue  1  7/166 (4.22%)  2/38 (5.26%)  0/37 (0.00%) 
Oedema peripheral  1  0/166 (0.00%)  0/38 (0.00%)  2/37 (5.41%) 
Infections and infestations       
Bronchitis  1  9/166 (5.42%)  5/38 (13.16%)  2/37 (5.41%) 
Gastroenteritis  1  12/166 (7.23%)  3/38 (7.89%)  5/37 (13.51%) 
Influenza  1  16/166 (9.64%)  5/38 (13.16%)  3/37 (8.11%) 
Nasopharyngitis  1  34/166 (20.48%)  10/38 (26.32%)  10/37 (27.03%) 
Pharyngitis  1  19/166 (11.45%)  2/38 (5.26%)  6/37 (16.22%) 
Respiratory tract infection  1  16/166 (9.64%)  3/38 (7.89%)  1/37 (2.70%) 
Rhinitis  1  23/166 (13.86%)  4/38 (10.53%)  4/37 (10.81%) 
Tonsillitis  1  8/166 (4.82%)  3/38 (7.89%)  5/37 (13.51%) 
Upper respiratory tract infection  1  23/166 (13.86%)  8/38 (21.05%)  6/37 (16.22%) 
Viral infection  1  9/166 (5.42%)  5/38 (13.16%)  3/37 (8.11%) 
Conjunctivitis  1  3/166 (1.81%)  2/38 (5.26%)  4/37 (10.81%) 
Cystitis  1  2/166 (1.20%)  2/38 (5.26%)  2/37 (5.41%) 
Ear infection  1  2/166 (1.20%)  0/38 (0.00%)  2/37 (5.41%) 
Gastroenteritis viral  1  4/166 (2.41%)  0/38 (0.00%)  2/37 (5.41%) 
Hordeolum  1  3/166 (1.81%)  2/38 (5.26%)  1/37 (2.70%) 
Otitis externa  1  1/166 (0.60%)  2/38 (5.26%)  0/37 (0.00%) 
Otitis media  1  3/166 (1.81%)  3/38 (7.89%)  0/37 (0.00%) 
Otitis media acute  1  4/166 (2.41%)  1/38 (2.63%)  2/37 (5.41%) 
Pharyngotonsillitis  1  1/166 (0.60%)  2/38 (5.26%)  0/37 (0.00%) 
Urinary tract infection  1  4/166 (2.41%)  3/38 (7.89%)  0/37 (0.00%) 
Varicella  1  5/166 (3.01%)  2/38 (5.26%)  2/37 (5.41%) 
Injury, poisoning and procedural complications       
Contusion  1  4/166 (2.41%)  2/38 (5.26%)  0/37 (0.00%) 
Fall  1  2/166 (1.20%)  0/38 (0.00%)  3/37 (8.11%) 
Joint injury  1  0/166 (0.00%)  1/38 (2.63%)  2/37 (5.41%) 
Ligament sprain  1  5/166 (3.01%)  0/38 (0.00%)  2/37 (5.41%) 
Investigations       
Blood creatine phosphokinase increased  1  2/166 (1.20%)  3/38 (7.89%)  1/37 (2.70%) 
Lipase increased  1  3/166 (1.81%)  2/38 (5.26%)  0/37 (0.00%) 
Metabolism and nutrition disorders       
Iron deficiency  1  10/166 (6.02%)  3/38 (7.89%)  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  25/166 (15.06%)  8/38 (21.05%)  6/37 (16.22%) 
Back pain  1  9/166 (5.42%)  3/38 (7.89%)  3/37 (8.11%) 
Juvenile idiopathic arthritis  1  21/166 (12.65%)  6/38 (15.79%)  6/37 (16.22%) 
Pain in extremity  1  9/166 (5.42%)  3/38 (7.89%)  7/37 (18.92%) 
Musculoskeletal chest pain  1  0/166 (0.00%)  1/38 (2.63%)  2/37 (5.41%) 
Musculoskeletal stiffness  1  0/166 (0.00%)  2/38 (5.26%)  1/37 (2.70%) 
Myalgia  1  2/166 (1.20%)  1/38 (2.63%)  2/37 (5.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1  4/166 (2.41%)  0/38 (0.00%)  2/37 (5.41%) 
Nervous system disorders       
Headache  1  26/166 (15.66%)  5/38 (13.16%)  7/37 (18.92%) 
Psychiatric disorders       
Attention deficit/hyperactivity disorder  1  0/166 (0.00%)  0/38 (0.00%)  2/37 (5.41%) 
Insomnia  1  1/166 (0.60%)  2/38 (5.26%)  0/37 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  2/166 (1.20%)  2/38 (5.26%)  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  23/166 (13.86%)  9/38 (23.68%)  3/37 (8.11%) 
Oropharyngeal pain  1  17/166 (10.24%)  6/38 (15.79%)  3/37 (8.11%) 
Epistaxis  1  2/166 (1.20%)  2/38 (5.26%)  1/37 (2.70%) 
Nasal congestion  1  2/166 (1.20%)  0/38 (0.00%)  2/37 (5.41%) 
Productive cough  1  0/166 (0.00%)  2/38 (5.26%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders       
Eczema  1  15/166 (9.04%)  1/38 (2.63%)  2/37 (5.41%) 
Pruritus  1  8/166 (4.82%)  2/38 (5.26%)  2/37 (5.41%) 
Rash  1  16/166 (9.64%)  3/38 (7.89%)  5/37 (13.51%) 
Urticaria  1  9/166 (5.42%)  1/38 (2.63%)  0/37 (0.00%) 
Dermatitis atopic  1  4/166 (2.41%)  0/38 (0.00%)  2/37 (5.41%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
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
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Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: +1 (862) 778-8300
EMail: Novartis.email@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02296424    
Other Study ID Numbers: CACZ885G2306
2013-004867-29 ( EudraCT Number )
First Submitted: October 10, 2014
First Posted: November 20, 2014
Results First Submitted: September 24, 2018
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019