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    Clinical Trial Results:
    A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS)

    Summary
    EudraCT number
    2009-016859-22
    Trial protocol
    FR   DE   ES   GB   BE   Outside EU/EEA   IE  
    Global end of trial date
    19 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    08 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885D2307
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01302860
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41  613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41  613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000060-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the efficacy of canakinumab with respect to the treatment response in subjects aged 4 years and younger.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed. Subjects who did not achieve a complete response following canakinumab subcutaneous (s.c.) injection, or who experienced a relapse before the next planned administration, were eligible for a dose up-titration as rescue medication.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Nov 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Switzerland: 2
    Worldwide total number of subjects
    17
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    6
    Children (2-11 years)
    11
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 14 centres in 7 countries.

    Pre-assignment
    Screening details
    A total of 17 subjects were enrolled into the study.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label, single-treatment arm study. Hence, blinding was not applicable.

    Arms
    Arm title
    Canakinumab
    Arm description
    Subjects received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Canakinumab s.c. injection (2 mg/kg) was administered every 8 weeks.

    Number of subjects in period 1
    Canakinumab
    Started
    17
    Completed
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Canakinumab
    Reporting group description
    Subjects received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.

    Reporting group values
    Canakinumab Total
    Number of subjects
    17 17
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    6 6
        Children (2-11 years)
    11 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    1.9 ± 1.39 -
    Gender categorical
    Units: Subjects
        Female
    5 5
        Male
    12 12

    End points

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    End points reporting groups
    Reporting group title
    Canakinumab
    Reporting group description
    Subjects received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.

    Primary: Percentage of subjects aged 4 years or younger with at least one complete response at Week 56

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    End point title
    Percentage of subjects aged 4 years or younger with at least one complete response at Week 56 [1]
    End point description
    Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as C reactive protein (CRP) or Serum amyloid A protein (SAA) to be less than (<) 15 milligram per litre (mg/L) and <10 mg/L respectively. The analysis was performed in Full analysis set (FAS), defined as all subjects who received at least one dose of study drug under this study protocol.
    End point type
    Primary
    End point timeframe
    Week 56
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics was planned for this primary outcome measure.
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: Percentage of subjects
        number (not applicable)
    94.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects aged 2 years or younger with at least one complete response at Week 56

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    End point title
    Percentage of subjects aged 2 years or younger with at least one complete response at Week 56
    End point description
    Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of autoinflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as CRP or SAA to be <15 mg/L and <10 mg/L respectively. The analysis was performed in FAS population.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Canakinumab
    Number of subjects analysed
    10 [2]
    Units: Percentage of subjects
        number (not applicable)
    90
    Notes
    [2] - Subjects aged 2 years or younger
    No statistical analyses for this end point

    Secondary: Percentage of subjects assessed for auto inflammatory disease activity by using physician’s global assessment score at Week 56

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    End point title
    Percentage of subjects assessed for auto inflammatory disease activity by using physician’s global assessment score at Week 56
    End point description
    Subjects were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. The analysis was performed in FAS population. "Number of Subject analyzed" is the total number of patients with non-missing assessment at the time point.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: Percentage of subjects
    number (not applicable)
        Absent
    70.6
        Minimal
    23.5
        Mild
    0
        Moderate
    5.9
        Severe
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with assessment of skin disease by using physician’s global assessment score at Week 56

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    End point title
    Percentage of subjects with assessment of skin disease by using physician’s global assessment score at Week 56
    End point description
    Subjects were assessed by physician for skin disease (urticarial skin rash) on a 5-­point scale as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. The analysis was performed in FAS population. "Number of Subject analyzed" is the total number of patients with non-missing assessment at the time point.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: Percentage of subjects
    number (not applicable)
        Absent
    82.4
        Minimal
    5.9
        Mild
    11.8
        Moderate
    0
        Severe
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) concentrations at Week 56

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    End point title
    Change from baseline in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) concentrations at Week 56
    End point description
    The CRP and SAA were used as inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement. The analysis was performed in FAS population. Here ‘n’ signifies those subjects with evaluable measurements at both baseline and the post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 56
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: mg/L
    arithmetic mean (standard deviation)
        CRP (n=14)
    -5.4 ± 6.28
        SAA (n=16)
    -54.4 ± 133.81
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    Adverse events (AEs) were defined as any unfavourable 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 ongenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. The analysis was performed in the safety set population defined as subjects who received at least one dose of study drug. Here, ‘n’ signifies subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 (start of study treatment) up to Week 56 (end of study)
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: Subjects
    number (not applicable)
        AEs (Overall, n=17)
    17
        SAEs (Overall, n=17)
    4
        AEs (Subjects <=2 years, n=10)
    10
        SAEs (Subjects <=2 years, n=10)
    3
    No statistical analyses for this end point

    Secondary: Percentage of subjects receiving a concomitant vaccination during the study

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    End point title
    Percentage of subjects receiving a concomitant vaccination during the study
    End point description
    Subjects receiving any one of the following inactivated vaccines as per the immunization program: Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, Influenza type A, Influenza type B, Haemophilus influenza B, Streptococcus pneumoniae, or Hepatitis B were determined. The analysis was performed in the FAS population.
    End point type
    Secondary
    End point timeframe
    Day 1 (start of study treatment) to Week 56 (end of study)
    End point values
    Canakinumab
    Number of subjects analysed
    17
    Units: Percentage of subjects
        number (not applicable)
    41.2
    No statistical analyses for this end point

    Secondary: Number of vaccination cases with protective antibody levels following immunization with inactivated vaccines

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    End point title
    Number of vaccination cases with protective antibody levels following immunization with inactivated vaccines
    End point description
    Subjects who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Subject vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study. The analysis was performed in the FAS population. The data reported in the table based on antibody levels are reporting number of vaccination cases in the respective categories.
    End point type
    Secondary
    End point timeframe
    Day -14 (prior-vaccination), Day 0 (vaccination), Day 28, Day 57 (post-vaccination)
    End point values
    Canakinumab
    Number of subjects analysed
    7 [3]
    Units: vaccination cases
    number (not applicable)
        Positive response for antibody levels
    18
        No pre-dose antibody levels
    13
    Notes
    [3] - Evaluable subjects who had total 31 vaccinations during study.
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-canakinumab antibodies at Week 56

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    End point title
    Number of subjects with anti-canakinumab antibodies at Week 56
    End point description
    Immunogenicity assessment included determination of anti­canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance tehnique. The analysis was performed in the safety set population. Here, ‘Number of subjects analysed’ signifies subjects who had immunogenicity samples taken and analyzed during the study.
    End point type
    Secondary
    End point timeframe
    Week 56 (end of study)
    End point values
    Canakinumab
    Number of subjects analysed
    15
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until Last Subject Last Visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Canakinumab
    Reporting group description
    Subjects received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.

    Serious adverse events
    Canakinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 17 (23.53%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Cryopyrin associated periodic syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cryptorchism
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Canakinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    Surgical and medical procedures
    Hearing aid therapy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    13
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    7
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Investigations
    CSF white blood cell count increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Cryopyrin associated periodic syndrome
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Nervous system disorders
    Speech disorder developmental
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Motor developmental delay
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    15
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Papilloedema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    6
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    16
    Toothache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Skin lesion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Bronchitis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Ear infection
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    6
    Eczema infected
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Gastritis viral
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Enterobiasis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    8
    Molluscum contagiosum
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Laryngitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oral fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    11
    Pharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Otitis externa
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Tinea pedis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    11
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Oct 2010
    1. Dose rationale for the dosing regimen for the study was outlined 2. Exclusion criteria related to live vaccinations was corrected 3. Paediatric subjects with neutropenia were excluded from receiving canakinumab treatment 4. Periodic assessment of neutrophil counts was introduced to monitor and detect neutropenia in subjects while receiving canakinumab treatment

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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