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    Clinical Trial Results:
    A Two-stage 6-month, Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Patients with Symptomatic Knee Osteoarthritis

    Summary
    EudraCT number
    		 2015-002117-30
    Trial protocol
    		 BE  
    Global end of trial date
    27 Apr 2018

    Results information
    Results version number
    		 v1
    This version publication date
    01 Nov 2019
    First version publication date
    01 Nov 2019
    Other versions
    		 v2
    Summary report(s)
    		 Study synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    000010/BT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bone Therapeutics S.A.
    Sponsor organisation address
    rue Auguste Picard 37, Gosselies, Belgium, B-6041
    Public contact
    Clinical Trial Information, Bone Therapeutics S.A., jta.koa1@bonetherapeutics.com
    Scientific contact
    Clinical Trial Information, Bone Therapeutics S.A., jta.koa1@bonetherapeutics.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the safety and efficacy of JTA-004® single intra-articular administration in patients suffering from symptomatic osteoarthritis of the knee at the end of the study period (at Month 6). Safety: At each follow-up visit, patients will be assessed for the occurrence of any (serious) adverse events using patient open non-directive questionnaire, physical examination (including vital signs), and laboratory measurements. The safety analyses will be based on incidence evaluation of treatment emergent adverse events by preferred term and body system. Laboratory measurements will be compared to the normal laboratory ranges and to laboratory measurements obtained at Baseline Visit. Efficacy: Primary study objectives are (i) the selection of the best JTA-004® strength and (ii) the superiority assessment of the best JTA-004® strength efficacy to the reference or (iii) stop the trial at interim analysis for futility.
    Protection of trial subjects
    Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2016
    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
    Belgium: 164
    Worldwide total number of subjects
    164
    EEA total number of subjects
    164
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    55
    From 65 to 84 years
    109
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Men and women, aged 50 to 79 years old, diagnosed with primary knee OA having a previous insufficient/failed response to analgesics and/or nonsteroidal antiinflammatory drugs (NSAIDs).

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    The Investigators were blind to treatment assignments with respect to the patient evaluation. They recruited, included and assessed patients during the whole study followup period, but did not treat the patients. Investigators were therefore not aware of treatment assignment. Patients were blind to treatment assignment

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JTA-004 50 2 mL
    Arm description
    		 Sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg; 2 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 JTA-004 50 4 mL
    Arm description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg/ml. 4 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 JTA-004 100 2 mL
    Arm description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 100 μg/ml. 2 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 100
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 Synvisc One
    Arm description
    		 Synvisc-One
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Synvisc-One
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single injection

    Number of subjects in period 1
    		JTA-004 50 2 mL JTA-004 50 4 mL JTA-004 100 2 mL Synvisc One
    Started
    41
    41
    41
    41
    Completed
    41
    41
    41
    41
    Period 2
    Period 2 title
    Final analysis
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    The Investigators were blind to treatment assignments with respect to the patient evaluation. They recruited, included and assessed patients during the whole study followup period, but did not treat the patients. Investigators were therefore not aware of treatment assignment. Patients were blind to treatment assignment same intra-articular injection (performed by the Independent Physicians). As the appearance of the resuspended JTA-004 was differ

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JTA-004 50 2 mL
    Arm description
    		 Sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg; 2 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 JTA-004 50 4 mL
    Arm description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg/ml. 4 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 JTA-004 100 2 mL
    Arm description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 100 μg/ml. 2 mL injected
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTA-004 100
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single intra-articular injection

    Arm title
    		 Synvisc One
    Arm description
    		 Synvisc-One
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Synvisc-One
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Single injection

    Number of subjects in period 2
    		JTA-004 50 2 mL JTA-004 50 4 mL JTA-004 100 2 mL Synvisc One
    Started
    41
    41
    41
    41
    Completed
    41
    41
    41
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 Adults

    Reporting group values
    		 Screening Total
    Number of subjects
    		 164 164
    Age categorical
    Adults
    Units: Subjects
        Adults
    		 164 164
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ± 7.5 -
    Gender categorical
    Units: Subjects
        Female
    		 112 112
        Male
    		 52 52

    End points

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    End points reporting groups
    Reporting group title
    JTA-004 50 2 mL
    Reporting group description
    		 Sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg; 2 mL injected

    Reporting group title
    JTA-004 50 4 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg/ml. 4 mL injected

    Reporting group title
    JTA-004 100 2 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 100 μg/ml. 2 mL injected

    Reporting group title
    Synvisc One
    Reporting group description
    		 Synvisc-One
    Reporting group title
    JTA-004 50 2 mL
    Reporting group description
    		 Sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg; 2 mL injected

    Reporting group title
    JTA-004 50 4 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg/ml. 4 mL injected

    Reporting group title
    JTA-004 100 2 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 100 μg/ml. 2 mL injected

    Reporting group title
    Synvisc One
    Reporting group description
    		 Synvisc-One

    Primary: Womac pain subscale change from baseline

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    End point title
    		 Womac pain subscale change from baseline
    End point description
    The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
    End point type
    Primary
    End point timeframe
    Evaluation at month 6
    End point values
    		 JTA-004 100 2 mL Synvisc One
    Number of subjects analysed
    41
    41
    Units: mm
        arithmetic mean (standard deviation)
    -26.7 ± 28.9
    -11.3 ± 27.9
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
    Comparison groups
    JTA-004 100 2 mL v Synvisc One
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.21
         upper limit
    		 3.23

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 months post injection
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    JTA-004 50 2 mL
    Reporting group description
    		 Sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg; 2 mL injected

    Reporting group title
    JTA-004 50 4 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 50 μg/ml. 4 mL injected

    Reporting group title
    JTA-004 100 2 mL
    Reporting group description
    		 sodium hyaluronate content was 20 mg and the concentration of clonidine was 100 μg/ml. 2 mL injected

    Reporting group title
    Synvisc One
    Reporting group description
    		 Synvisc-One

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Full display of non serious AEs are in the attached summary report
    Serious adverse events
    		 JTA-004 50 2 mL JTA-004 50 4 mL JTA-004 100 2 mL Synvisc One
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 41 (9.76%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 41 (4.88%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Barett's oesophagus
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaorrhea
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernia eventration
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Rectocele
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Osteomyelitis acute
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 JTA-004 50 2 mL JTA-004 50 4 mL JTA-004 100 2 mL Synvisc One
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2016
    Amendment 1
    10 May 2017
    Amendment 2

    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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