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    Clinical Trial Results:
    An open label, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of Lopain (MTX-071) in patients with chronic osteoarthritic knee joint pain after a single dose (Part 1) and after repeated dose administration (Part 2)

    Summary
    EudraCT number
    		 2015-001981-24
    Trial protocol
    		 BE  
    Global end of trial date
    24 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MTX-071-P01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mestex AG
    Sponsor organisation address
    Klosterberg 11, Basel, Switzerland, CH-4051
    Public contact
    Grünenthal Trial Information Desk, Mestex AG, Clinical-Trials@grunenthal.com
    Scientific contact
    Grünenthal Trial Information Desk, Mestex AG, Clinical-Trials@grunenthal.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
    24 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part I: The primary objective was the safety and tolerability of intra-articular injection of MTX-071 in incrementing doses based on the incidence, nature and severity of AES/SAEs potentially causally related with the study medication. Part II: The primary objective was the safety and tolerability of a second and a third intra-articular injection of MTX-071 on the incidence, nature and severity of AES/SAEs potentially causally related with the study medication.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95) and with applicable local requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    18
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at two orthopedic clinics experienced in the treatment of osteoarthritis of the knee.

    Pre-assignment
    Screening details
    		 20 subjects were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MTX-071 Group 1 - (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 5 - PA (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    No local anesthetics, with oral premedication (600 mg ibuprofen) and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 2 - (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 6 - PA (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    No local anesthetics, with oral premedication (600 mg ibuprofen) and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 3 - (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 7 - PA (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    No local anesthetics, with oral premedication (600 mg ibuprofen) and a single dose of MTX-071

    Arm title
    		 MTX-071 Group 4 - (Part 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a single dose of MTX-071

    Number of subjects in period 1
    		MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Started
    3
    4
    3
    3
    3
    1
    3
    Completed
    3
    4
    3
    3
    3
    0
    3
    Not completed
    0
    0
    0
    0
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    1
    -
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 MTX-071 Group 1 - (Part 2) second injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a second single dose of MTX-071

    Arm title
    		 MTX-071 Group 5 - PA (Part 2) second injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    No local anesthetics, with oral premedication (600 mg ibuprofen) and a second single dose of MTX-071

    Arm title
    		 MTX-071 Group 1 - (Part 2) third injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopain
    Investigational medicinal product code
    MTX-071
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Local anesthetics (5 mL of ropivacaine 0.5%, IA), without oral premedication and a third single dose of MTX-071

    Number of subjects in period 2
    		MTX-071 Group 1 - (Part 2) second injection MTX-071 Group 5 - PA (Part 2) second injection MTX-071 Group 1 - (Part 2) third injection
    Started
    7
    1
    3
    Completed
    2
    1
    3
    Not completed
    5
    0
    0
         Consent withdrawn by subject
    2
    -
    -
         failure to continue
    3
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        From 47 - 75 years
    		 20 20
    Age continuous
    Units: years
        median (full range (min-max))
    		 57.5 (47 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 10 10

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MTX-071 Group 1 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 2 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 6 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 3 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 7 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 4 - (Part 1)
    Reporting group description
    		 -
    Reporting group title
    MTX-071 Group 1 - (Part 2) second injection
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - PA (Part 2) second injection
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 1 - (Part 2) third injection
    Reporting group description
    		 -

    Subject analysis set title
    MTX-071 Group 1 - second injection
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    efficacy

    Subject analysis set title
    MTX-071 Group 1 - third injection
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    efficacy

    Primary: Treatment-emergent adverse events (Part 1)

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    End point title
    		 Treatment-emergent adverse events (Part 1) [1]
    End point description
    Analysis was performed on Safety population i.e. subjects were analysed according to the treatment actually received.
    End point type
    Primary
    End point timeframe
    Continuous assessment up to 6 months after injection.
    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: Descriptively only
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    1
    3
    Units: subjects
        At least one TEAE
    3
    4
    3
    3
    3
    1
    3
        At least one serious TEAE
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE leading to death
    0
    0
    0
    0
    0
    0
    0
        At least one grade 1 TEAE as worst severity
    0
    2
    1
    0
    0
    0
    2
        At least one grade 2 TEAE as worst severity
    2
    1
    1
    1
    1
    0
    0
        At least one grade 3 TEAE as worst severity
    1
    1
    1
    2
    2
    1
    1
        At least one grade 4 TEAE as worst severity
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE drug discontinued temporarily
    0
    0
    0
    0
    0
    0
    0
        At least one TEAE drug discontinued permanently
    0
    0
    0
    0
    0
    0
    0
        At least one treatment-related TEAE
    2
    4
    2
    3
    3
    1
    3
    No statistical analyses for this end point

    Primary: Treatment-emergent adverse events (Part 2)

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    End point title
    		 Treatment-emergent adverse events (Part 2) [2]
    End point description
    Analysis was performed on Safety population i.e. subjects were analysed according to the treatment actually received.
    End point type
    Primary
    End point timeframe
    Continuous assessment up to 6 months after injection.
    Notes
    [2] - 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: Descriptively only
    End point values
    		 MTX-071 Group 1 - (Part 2) second injection MTX-071 Group 5 - PA (Part 2) second injection MTX-071 Group 1 - (Part 2) third injection
    Number of subjects analysed
    7
    1
    3
    Units: subjects
        At least one TEAE
    6
    1
    3
        At least one serious TEAE
    0
    0
    0
        At least one TEAE leading to death
    0
    0
    0
        At least one grade 1 TEAE as worst severity
    2
    0
    0
        At least one grade 2 TEAE as worst severity
    3
    1
    3
        At least one grade 3 TEAE as worst severity
    1
    0
    0
        At least one grade 4 TEAE as worst severity
    0
    0
    0
        At least one TEAE drug discontinued temporarily
    0
    0
    0
        At least one TEAE drug discontinued permanently
    0
    0
    0
        At least one treatment-related TEAE
    4
    1
    3
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 1) - treated knee in motion over last 2 days

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    End point title
    		 VAS efficacy changes from baseline (Part 1) - treated knee in motion over last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on Intent-to-Treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    0 [3]
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    -20.33 ± 32.808
    -36.50 ± 20.984
    -67.00 ± 17.776
    -56.00 ± 18.735
    -23.67 ± 33.787
    ±
    -53.33 ± 21.362
        Day 30
    -40.67 ± 15.144
    -47.25 ± 11.266
    -65.00 ± 23.388
    -52.33 ± 20.502
    -33.00 ± 37.172
    ±
    -55.67 ± 17.388
        Day 90
    -44.00 ± 8.718
    -39.50 ± 22.368
    -53.00 ± 8.888
    -41.33 ± 18.930
    -32.67 ± 38.027
    ±
    -60.67 ± 6.110
        Day 180
    -42.67 ± 11.240
    -18.75 ± 17.933
    -66.33 ± 23.094
    -41.00 ± 28.054
    -38.67 ± 33.137
    ±
    -56.00 ± 6.083
    Notes
    [3] - Subject withdraw consent
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 1) - treated knee in motion over last 7 days

    		 Close Top of page
    End point title
    		 VAS efficacy changes from baseline (Part 1) - treated knee in motion over last 7 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    0 [4]
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    -36.50 ± 26.837
    -42.50 ± 19.434
    -45.50 ± 7.858
    -44.00 ± 15.716
    -18.67 ± 26.764
    ±
    -55.67 ± 23.438
        Day 30
    -54.50 ± 26.725
    -57.25 ± 10.308
    -53.50 ± 16.454
    -43.67 ± 28.937
    -26.33 ± 29.738
    ±
    -53.00 ± 28.792
        Day 90
    -57.17 ± 24.609
    -48.75 ± 29.748
    -40.83 ± 14.683
    -41.67 ± 17.010
    -27.00 ± 30.414
    ±
    -65.33 ± 7.638
        Day 180
    -59.50 ± 20.573
    -27.25 ± 23.726
    -53.17 ± 18.044
    -37.00 ± 24.269
    -33.33 ± 23.692
    ±
    -59.67 ± 7.234
    Notes
    [4] - Subject withdraw consent
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 1) - treated knee in rest over last 2 days

    		 Close Top of page
    End point title
    		 VAS efficacy changes from baseline (Part 1) - treated knee in rest over last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    0 [5]
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    2.67 ± 12.342
    -35.50 ± 21.424
    -45.33 ± 33.005
    -48.67 ± 12.097
    -31.00 ± 29.309
    ±
    -50.83 ± 11.295
        Day 30
    -11.17 ± 2.754
    -48.75 ± 13.672
    -46.67 ± 37.072
    -50.33 ± 22.279
    -35.00 ± 34.044
    ±
    -53.17 ± 8.808
        Day 90
    -11.50 ± 3.279
    -40.25 ± 26.998
    -23.67 ± 23.861
    -38.67 ± 11.930
    -35.00 ± 38.039
    ±
    -55.50 ± 6.144
        Day 180
    -11.83 ± 1.756
    -23.75 ± 35.481
    -46.67 ± 38.501
    -34.00 ± 28.844
    -38.67 ± 35.501
    ±
    -52.83 ± 9.878
    Notes
    [5] - Subject withdraw consent
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 1) - treated knee in rest over last 7 days

    		 Close Top of page
    End point title
    		 VAS efficacy changes from baseline (Part 1) - treated knee in rest over last 7 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    0 [6]
    3
    Units: score
    arithmetic mean (standard deviation)
        Day 7
    0.50 ± 9.124
    -37.75 ± 16.215
    -33.33 ± 28.042
    -40.67 ± 13.051
    -26.50 ± 18.296
    ±
    -53.67 ± 11.504
        Day 30
    -11.50 ± 9.987
    -50.00 ± 8.832
    -43.00 ± 27.622
    -47.33 ± 26.274
    -28.17 ± 25.702
    ±
    -55.67 ± 9.609
        Day 90
    -14.50 ± 9.526
    -42.00 ± 27.191
    -24.00 ± 25.120
    -42.00 ± 9.539
    -27.17 ± 28.550
    ±
    -57.67 ± 8.327
        Day 180
    -14.17 ± 8.221
    -25.25 ± 36.873
    -43.00 ± 26.211
    -29.67 ± 24.132
    -31.17 ± 24.761
    ±
    -54.67 ± 10.970
    Notes
    [6] - Subject withdraw consent
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 2) - treated knee in motion over last 2 days

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    End point title
    		 VAS efficacy changes from baseline (Part 2) - treated knee in motion over last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection and 60, 120 and 150 days after injection (telephone call with patient)
    End point values
    		 MTX-071 Group 1 - second injection MTX-071 Group 1 - third injection
    Number of subjects analysed
    7
    3
    Units: score
    arithmetic mean (standard error)
        Day 7
    -21.29 ± 7.730
    -24.00 ± 6.807
        Day 30
    -14.83 ± 11.083
    -20.00 ± 4.041
        Day 60
    -30.71 ± 10.179
    -30.00 ± 5.132
        Day 90
    -31.00 ± 7.859
    -31.67 ± 3.383
        Day 120
    -19.57 ± 11.189
    -25.67 ± 7.839
        Day 150
    -16.14 ± 13.965
    -30.67 ± 4.842
        Day 180
    -27.71 ± 10.122
    -29.33 ± 7.860
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 2) - treated knee in motion over last 7 days

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    End point title
    		 VAS efficacy changes from baseline (Part 2) - treated knee in motion over last 7 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection and 60, 120 and 150 days after injection (telephone call with patient).
    End point values
    		 MTX-071 Group 1 - second injection MTX-071 Group 1 - third injection
    Number of subjects analysed
    7
    3
    Units: score
    arithmetic mean (standard error)
        Day 7
    -21.14 ± 6.602
    -22.00 ± 7.937
        Day 30
    -19.33 ± 10.362
    -24.67 ± 2.333
        Day 60
    -31.86 ± 9.349
    -28.00 ± 5.859
        Day 90
    -31.00 ± 8.813
    -24.00 ± 10.263
        Day 120
    -18.57 ± 11.406
    -22.00 ± 13.013
        Day 150
    -12.57 ± 15.578
    -29.00 ± 9.074
        Day 180
    -25.86 ± 10.122
    -27.67 ± 11.921
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 2) - treated knee in rest over last 2 days

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    End point title
    		 VAS efficacy changes from baseline (Part 2) - treated knee in rest over last 2 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    "Baseline, 7 days, 30 days, 90 days and 180 days after injection and 60, 120 and 150 days after injection (telephone call with patient).
    End point values
    		 MTX-071 Group 1 - second injection MTX-071 Group 1 - third injection
    Number of subjects analysed
    7
    3
    Units: score
    arithmetic mean (standard error)
        Day 7
    -19.14 ± 10.347
    -16.33 ± 12.441
        Day 30
    -15.67 ± 12.110
    -9.33 ± 13.679
        Day 60
    -22.43 ± 13.582
    -25.00 ± 15.044
        Day 90
    -29.71 ± 9.138
    -12.67 ± 6.333
        Day 120
    -19.14 ± 12.916
    -22.00 ± 15.588
        Day 150
    -14.43 ± 12.806
    -21.67 ± 14.530
        Day 180
    -25.14 ± 11.046
    -21.33 ± 13.593
    No statistical analyses for this end point

    Secondary: VAS efficacy changes from baseline (Part 2) - treated knee in rest over last 7 days

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    End point title
    		 VAS efficacy changes from baseline (Part 2) - treated knee in rest over last 7 days
    End point description
    The severity of arthritis pain in subject's knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicated more pain. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection and 60, 120 and 150 days after injection (telephone call with patient).
    End point values
    		 MTX-071 Group 1 - second injection MTX-071 Group 1 - third injection
    Number of subjects analysed
    7
    3
    Units: score
    arithmetic mean (standard error)
        Day 7
    -15.57 ± 9.307
    -12.67 ± 17.247
        Day 30
    -17.67 ± 11.704
    -12.67 ± 12.414
        Day 60
    -16.57 ± 13.136
    -26.33 ± 13.170
        Day 90
    -25.57 ± 10.181
    -12.33 ± 5.897
        Day 120
    -14.14 ± 13.154
    -21.33 ± 14.438
        Day 150
    -6.00 ± 17.562
    -22.00 ± 13.317
        Day 180
    -15.71 ± 11.195
    -23.33 ± 12.143
    No statistical analyses for this end point

    Secondary: Changes in total WOMAC score versus basline (Part 1)

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    End point title
    		 Changes in total WOMAC score versus basline (Part 1)
    End point description
    WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, subject-relevant symptoms for pain, stiffness and physical function in subjects with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, 7 days, 30 days, 90 days and 180 days after injection.
    End point values
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1)
    Number of subjects analysed
    3
    4
    3
    3
    3
    0 [7]
    3
    Units: score
    arithmetic mean (standard error)
        Day 7
    -9.0 ± 5.20
    -22.5 ± 4.33
    -19.0 ± 4.93
    -37.3 ± 6.89
    -0.3 ± 2.96
    ±
    -24.0 ± 10.21
        Day 30
    -32.7 ± 8.41
    -25.0 ± 5.20
    -28.0 ± 4.16
    -41.3 ± 17.36
    -4.0 ± 2.00
    ±
    -28.7 ± 6.77
        Day 90
    -37.0 ± 9.85
    -15.5 ± 9.04
    -16.0 ± 10.97
    -40.7 ± 9.91
    -14.0 ± 5.57
    ±
    -28.7 ± 7.45
        Day 180
    -37.7 ± 10.04
    -7.3 ± 7.42
    -21.3 ± 4.18
    -43.3 ± 10.97
    -23.0 ± 12.34
    ±
    -31.3 ± 6.39
    Notes
    [7] - Subject withdraw consent
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 months after injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    MTX-071 Group 1 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 2 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 6 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 3 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 7 - PA (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 4 - (Part 1)
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 1 - (Part 2) second injection
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 5 - PA (Part 2) second injection
    Reporting group description
    		 -

    Reporting group title
    MTX-071 Group 1 - (Part 2) third injection
    Reporting group description
    		 -

    Serious adverse events
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1) MTX-071 Group 1 - (Part 2) second injection MTX-071 Group 5 - PA (Part 2) second injection MTX-071 Group 1 - (Part 2) third injection
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MTX-071 Group 1 - (Part 1) MTX-071 Group 5 - PA (Part 1) MTX-071 Group 2 - (Part 1) MTX-071 Group 6 - PA (Part 1) MTX-071 Group 3 - (Part 1) MTX-071 Group 7 - PA (Part 1) MTX-071 Group 4 - (Part 1) MTX-071 Group 1 - (Part 2) second injection MTX-071 Group 5 - PA (Part 2) second injection MTX-071 Group 1 - (Part 2) third injection
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    6 / 7 (85.71%)
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Injection site joint pain
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 4 (100.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    4 / 7 (57.14%)
    1 / 1 (100.00%)
    2 / 3 (66.67%)
         occurrences all number
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    Injection site pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    1
    1
    0
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2016
    Addition of additional subjects and change of premedication
    16 Jan 2017
    Addition of part 2 with repeated dose.
    02 Feb 2018
    Change in Principal Investigator, new batches of RTX and buffer for administration of third dose, extension of period of inclusion after the second administration from 9 to 12 months.

    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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