Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open­label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2015-002466-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Nov 2003

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2016
    First version publication date
    27 Nov 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    990758
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00037648
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 3611
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Dr, Thousand Oaks, United States, CA 90049
    Public contact
    Terry Bevirt Therapeutic Area Planning & Operations Director Early Development , Amgen Inc., 001 805-447-0507, tbevirt@amgen.com
    Scientific contact
    Terry Bevirt Therapeutic Area Planning & Operations Director Early Development , Amgen Inc., 001 805-447-0507, tbevirt@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001212-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2003
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2003
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2003
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the safety of anakinra
    Protection of trial subjects
    This study was conducted in compliance with principles of the Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) regulations/guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2000
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    United States: 51
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    Costa Rica: 13
    Worldwide total number of subjects
    86
    EEA total number of subjects
    0
    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)
    0
    Children (2-11 years)
    43
    Adolescents (12-17 years)
    43
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Multicenter study conducted at 17 centers in the United States, Canada, Australia, New Zealand and Costa Rica

    Pre-assignment
    Screening details
    		 Screening up to 4 weeks prior to enrolment

    Period 1
    Period 1 title
    Open label phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-label Kineret
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anakinra
    Investigational medicinal product code
    Other name
    Kineret
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC anakinra 1.0 mg/kg/day up to a maximum of 100 mg/day for 12 weeks

    Number of subjects in period 1
    		Open-label Kineret
    Started
    86
    Completed
    50
    Not completed
    36
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    4
         Administrative decision
    1
         Non-responders (protocol-specified criteria)
    27
         Protocol deviation
    1
    Period 2
    Period 2 title
    Blinded phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Kineret
    Arm description
    		 16-week blinded, placebo-controlled phase with a 2-week follow-up visit
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anakinra
    Investigational medicinal product code
    Other name
    Kineret
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC anakinra 1.0 mg/kg/day up to a maximum of 100 mg/day for 16 weeks

    Arm title
    		 Placebo
    Arm description
    		 16-week blinded, placebo-controlled phase with a 2-week follow-up visit
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received daily SC blinded doses of placebo for 16 weeks. Placebo was supplied in single-use vials, identical to anakinra.

    Number of subjects in period 2
    		Kineret Placebo
    Started
    25
    25
    Completed
    19
    12
    Not completed
    6
    13
         Disease flare
    6
    12
         Administrative decision
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Open label phase
    Reporting group description
    		 -

    Reporting group values
    		 Open label phase Total
    Number of subjects
    		 86 86
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 43 43
        Adolescents (12-17 years)
    		 43 43
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.51 ( 3.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 63 63
        Male
    		 23 23
    Type of arthritis at onset
    Units: Subjects
        Pauciarticular
    		 9 9
        Polyarticular
    		 62 62
        Systemic
    		 15 15
    Duration of JRA
    Units: years
        arithmetic mean (standard deviation)
    		 4.7 ( 3.7 ) -
    Subject analysis sets

    Subject analysis set title
    Kineret open-label phase
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of open-label study drug were considered evaluable for safety.

    Subject analysis set title
    Kineret double-blind phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to Kineret.

    Subject analysis set title
    Placebo double-blind phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to placebo.

    Subject analysis set title
    Kineret double-blind phase - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of blinded study drug were considered evaluable for safety.

    Subject analysis set title
    Placebo double-blind phase - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of blinded study drug were considered evaluable for safety.

    Subject analysis sets values
    		 Kineret open-label phase Kineret double-blind phase Placebo double-blind phase Kineret double-blind phase - Safety Placebo double-blind phase - Safety
    Number of subjects
    86
    25
    25
    25
    25
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
    43
        Adolescents (12-17 years)
    43
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.51 ( 3.88 )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Type of arthritis at onset
    Units: Subjects
        Pauciarticular
        Polyarticular
        Systemic
    Duration of JRA
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Open-label Kineret
    Reporting group description
    		 -
    Reporting group title
    Kineret
    Reporting group description
    		 16-week blinded, placebo-controlled phase with a 2-week follow-up visit

    Reporting group title
    Placebo
    Reporting group description
    		 16-week blinded, placebo-controlled phase with a 2-week follow-up visit

    Subject analysis set title
    Kineret open-label phase
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of open-label study drug were considered evaluable for safety.

    Subject analysis set title
    Kineret double-blind phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to Kineret.

    Subject analysis set title
    Placebo double-blind phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to placebo.

    Subject analysis set title
    Kineret double-blind phase - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of blinded study drug were considered evaluable for safety.

    Subject analysis set title
    Placebo double-blind phase - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of blinded study drug were considered evaluable for safety.

    Primary: Proportion of subjects with disease flares during the 16-week blinded phase

    		 Close Top of page
    End point title
    		 Proportion of subjects with disease flares during the 16-week blinded phase
    End point description
    Time to flare was also analysed and the difference between groups was not significant. For neither of the groups, a median time could be estimated.
    End point type
    Primary
    End point timeframe
    From randomisation (week 12) to week 28 in the blinded phase
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    25
    25
    Units: Number of subjects
        Yes
    4
    9
        No
    21
    16
    Statistical analysis title
    		 Proportion of subjects with disease flares
    Comparison groups
    Kineret double-blind phase v Placebo double-blind phase
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1963
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change from week 12 assessments of CHAQ to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 assessments of CHAQ to week 28 (blinded phase)
    End point description
    CHAQ = Childhood Health Assessment Questionnaire
    End point type
    Secondary
    End point timeframe
    From week 12 (randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    11
    Units: score
        arithmetic mean (standard deviation)
    -0.25 ( 0.48 )
    0.13 ( 0.53 )
    No statistical analyses for this end point

    Secondary: Change from week 12 assessments of number of active joints to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 assessments of number of active joints to week 28 (blinded phase)
    End point description
    End point type
    Secondary
    End point timeframe
    From week 12 (Randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    11
    Units: Number of active joints
        arithmetic mean (standard deviation)
    -0.35 ( 5.46 )
    -0.64 ( 4.13 )
    No statistical analyses for this end point

    Secondary: Change from week 12 assessments of number of joints with limitation of motion to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 assessments of number of joints with limitation of motion to week 28 (blinded phase)
    End point description
    End point type
    Secondary
    End point timeframe
    From week 12 (Randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    11
    Units: Number of joints
        arithmetic mean (standard deviation)
    -0.6 ( 5.21 )
    0.18 ( 4.49 )
    No statistical analyses for this end point

    Secondary: Change from week 12 assessments of physicians assessment of JRA disease activity to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 assessments of physicians assessment of JRA disease activity to week 28 (blinded phase)
    End point description
    End point type
    Secondary
    End point timeframe
    From week 12 (Randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    11
    Units: score
        arithmetic mean (standard deviation)
    3.35 ( 20.11 )
    9.27 ( 34.18 )
    No statistical analyses for this end point

    Secondary: Change from week 12 assessments of subject/parent assessment of JRA disease activity to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 assessments of subject/parent assessment of JRA disease activity to week 28 (blinded phase)
    End point description
    End point type
    Secondary
    End point timeframe
    From week 12 (Randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    11
    Units: score
        arithmetic mean (standard deviation)
    -6.55 ( 11.25 )
    1.36 ( 25.36 )
    No statistical analyses for this end point

    Secondary: anti-Anakinra Antibodies

    		 Close Top of page
    End point title
    		 anti-Anakinra Antibodies
    End point description
    Occurence of antibodies at any time during the open-label period
    End point type
    Secondary
    End point timeframe
    From baseline to week 12 (open-label phase)
    End point values
    		 Kineret open-label phase
    Number of subjects analysed
    64
    Units: Subjects
        non-neutralising antibodies
    48
        Neutralising antibodies
    4
    No statistical analyses for this end point

    Secondary: anti-Anakinra Antibodies - double-blind phase

    		 Close Top of page
    End point title
    		 anti-Anakinra Antibodies - double-blind phase
    End point description
    Occurence of antibodies at any time during the double-blind period
    End point type
    Secondary
    End point timeframe
    From week 12 (randomisation) to week 28
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    18
    9
    Units: Subjects
        non-neutralising antibodies
    13
    4
        neutralising antibodies
    0
    1
    No statistical analyses for this end point

    Secondary: Change from week 12 in ESR to week 28 (blinded phase)

    		 Close Top of page
    End point title
    		 Change from week 12 in ESR to week 28 (blinded phase)
    End point description
    ESR = Erythrocyte Sedimentation Rate
    End point type
    Secondary
    End point timeframe
    From week 12 (randomisation) to week 28 (blinded phase)
    End point values
    		 Kineret double-blind phase Placebo double-blind phase
    Number of subjects analysed
    20
    15
    Units: mm/hr
        arithmetic mean (standard deviation)
    -3.7 ( 11.23 )
    13.73 ( 22.52 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From start of enrolment until end of blinded phase
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Open-label Kineret
    Reporting group description
    		 -

    Reporting group title
    Blinded phase - Kineret
    Reporting group description
    		 -

    Reporting group title
    Blinded phase - Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Open-label Kineret Blinded phase - Kineret Blinded phase - Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Open-label Kineret Blinded phase - Kineret Blinded phase - Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 86 (93.02%)
    17 / 25 (68.00%)
    18 / 25 (72.00%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    3 / 86 (3.49%)
    3 / 25 (12.00%)
    0 / 25 (0.00%)
         occurrences all number
    4
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 86 (22.09%)
    6 / 25 (24.00%)
    1 / 25 (4.00%)
         occurrences all number
    36
    10
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    31 / 86 (36.05%)
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    40
    3
    1
    Injection site haemorrhage
         subjects affected / exposed
    12 / 86 (13.95%)
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    18
    1
    4
    Injection site inflammation
         subjects affected / exposed
    8 / 86 (9.30%)
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    9
    0
    1
    Injection site oedema
         subjects affected / exposed
    9 / 86 (10.47%)
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences all number
    19
    1
    0
    Injection site pruritus
         subjects affected / exposed
    26 / 86 (30.23%)
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    36
    2
    1
    Injection site pain
         subjects affected / exposed
    29 / 86 (33.72%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    57
    0
    0
    Injection site rash
         subjects affected / exposed
    14 / 86 (16.28%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    19
    0
    0
    Injection site reaction
         subjects affected / exposed
    13 / 86 (15.12%)
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences all number
    14
    2
    0
    Pain
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    9
    0
    7
    Pyrexia
         subjects affected / exposed
    14 / 86 (16.28%)
    3 / 25 (12.00%)
    2 / 25 (8.00%)
         occurrences all number
    21
    4
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 86 (17.44%)
    3 / 25 (12.00%)
    2 / 25 (8.00%)
         occurrences all number
    19
    5
    2
    Diarrhoea
         subjects affected / exposed
    7 / 86 (8.14%)
    3 / 25 (12.00%)
    0 / 25 (0.00%)
         occurrences all number
    7
    3
    0
    Nausea
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    8
    0
    1
    Vomiting
         subjects affected / exposed
    6 / 86 (6.98%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    12
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 86 (5.81%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    5
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    5 / 86 (5.81%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    5
    2
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    2 / 86 (2.33%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    9 / 86 (10.47%)
    0 / 25 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    13
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 86 (12.79%)
    1 / 25 (4.00%)
    4 / 25 (16.00%)
         occurrences all number
    21
    1
    6
    Arthritis
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Back pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    0
    3
    Joint stiffness
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    0
    2
    Pain in extremity
         subjects affected / exposed
    6 / 86 (6.98%)
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    6
    3
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 86 (23.26%)
    4 / 25 (16.00%)
    5 / 25 (20.00%)
         occurrences all number
    22
    4
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2000
    Amendment 1: • Increased sample size from 150 to 204 subjects in the open label phase and 50 to 68 subjects in the blinded phase • Revised inclusion and exclusion criteria • Clarified concomitant therapy use during the study • Included secondary objective of sustained response rate • General administrative changes and clarifications included typographical and spelling errors • Wording changed in Informed Consent document to lower the reading level score to a more appropriate level • Updated safety and efficacy profiles from recently completed IL-1ra studies
    17 Apr 2000
    Amendment 2: • Subject or parent pain assessment was included as a secondary objective • Maximum methotrexate dose was increased to 40 mg/wk • Eliminated 40 mg/mL study drug concentration • Clarified that subjects receiving methotrexate were to also receive folic acid or folinic acid • Clarified that subjects on stable doses of oral corticosteroids receive ≤ 10mg/day or 0.2 mg/kg/day of prednisone (whichever was less) • Added to exclusion criteria subjects known to be positive for hepatitis or HIV • Added to concomitant therapy that etanercept and infliximab be received 4 weeks prior to anakinra • Added to concomitant medication guidelines that subjects were allowed one intra-ocular corticosteroid injection in the case of uveitis

    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.
    CSP Amendment 3: CSP Amendment 3 (20Feb2004 post End of Trial). The objectives and statistical considerations of this protocol were changed to only evaluate the safety of anakinra in subjects with JRA.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 06:56:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA