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    Clinical Trial Results:
    A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren’s disease, with a dose response.

    Summary
    EudraCT number
    		 2015-001780-40
    Trial protocol
    		 GB  
    Global end of trial date
    10 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2022
    First version publication date
    19 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11069
    Additional study identifiers
    ISRCTN number
    		 ISRCTN27786905
    US NCT number
    		 NCT03180957
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Kennedy Institute of Rheumatology, Oxford, United Kingdom, OX7 7LD
    Public contact
    Nicola Kenealy, University of Oxford, 44 01865610612, nicola.kenealy@kennedy.ox.ac.uk
    Scientific contact
    Prof Jagdeep Nanchahal, University of Oxford, 44 01865 612633, jagdeep.nanchahal@kennedy.ox.ac.uk
    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
    02 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 2: To determine if injection with adalimumab is superior to placebo injection of normal saline in controlling disease progression in participants with early Dupuytren’s disease.
    Protection of trial subjects
    This study was conducted in accordance with local regulatory requirements, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and the ethical principles described in the current revision (2002) of Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 140
    Worldwide total number of subjects
    140
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    94
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment to RIDD was opened in December 2016, and the first participant was recruited in February 2017. 181 participants from the UK and NL were randomised over the period of 26 months. After excluding 8 randomisation that were in error, 173 (140 in the UK, 33 in NL) were included in the trial.

    Pre-assignment
    Screening details
    		 A total of 284 participants were screened for the RIDD trial out of these 284, 147 were randomised and 137 were ineligible. Participants were ineligible for the following reasons: o Not eligible (n = 112) (of which 8 failed safety screening) o Declined to participate (n = 20) o Not included due to end of recruitment (n = 5)

    Period 1
    Period 1 title
    Baseline Trial - UK
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    A non-blinded member of the research team, who was not involved in administering the IMP or assessing the participant, prepared the adalimumab or normal saline in a syringe according to the randomisation, and labelled the syringes with the participant’s ID. The label did not reveal the identity of the IMP. Both the IMP and placebo have a similar viscosity and appearance so that the two treatments, adalimumab or saline, were indistinguishable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab Baseline
    Arm description
    		 Anti-TNF Participants received the anti-TNF agent Adalimumab 40 mg in 0.4ml into the nodule at baseline, 3, 6 and 9 months after randomisation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    40mg adalimumab in 0.4 ml

    Arm title
    		 Placebo Baseline
    Arm description
    		 Placebo Participants received an injection of saline (placebo) of equivalent volume at baseline, 3, 6 and 9 months after randomisation
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    0.4 ml

    Number of subjects in period 1
    		Adalimumab Baseline Placebo Baseline
    Started
    70
    70
    Completed
    59
    54
    Not completed
    11
    16
         Lost to follow-up
    11
    16
    Period 2
    Period 2 title
    12 Months Follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab - 12 Months
    Arm description
    		 Anti-TNF Participants received the anti-TNF agent Adalimumab 40 mg in 0.4ml into the nodule at baseline, 3, 6 and 9 months after randomisation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    40mg adalimumab in 0.4 ml

    Arm title
    		 Placebo - 12 months
    Arm description
    		 Placebo Participants received an injection of saline (placebo) of equivalent volume at baseline, 3, 6 and 9 months after randomisation
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    0.4 ml

    Number of subjects in period 2
    		Adalimumab - 12 Months Placebo - 12 months
    Started
    59
    54
    Completed
    59
    54

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline Trial - UK
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Trial - UK Total
    Number of subjects
    		 140 140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 94 94
        From 65-84 years
    		 46 46
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.7 ( 10.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 47
        Male
    		 93 93
    Manual Occupation
    Units: Subjects
        Yes
    		 16 16
        No
    		 124 124
    Alcohol Consumption (units/week)
    Units: Subjects
        Non- Drinker
    		 16 16
        up to 13
    		 77 77
        14-35
    		 43 43
        Over 35
    		 4 4
    Current smoker
    Units: Subjects
        yes
    		 7 7
        no
    		 133 133
    Hand Dominance
    Units: Subjects
        right
    		 124 124
        left
    		 15 15
        Missing
    		 1 1
    Epilepsy
    Units: Subjects
        no
    		 137 137
        yes
    		 3 3
    Liver Disease
    Units: Subjects
        no
    		 140 140
    significant exposure to occupational vibration
    Units: Subjects
        no
    		 130 130
        yes
    		 10 10
    Previous significant trauma to affected hand
    Units: Subjects
        no
    		 113 113
        yes
    		 27 27
    Diabetes
    Units: Subjects
        no
    		 131 131
        type 1
    		 1 1
        type 2
    		 8 8
    Frozen Shoulder
    Units: Subjects
        none
    		 103 103
        right
    		 12 12
        left
    		 15 15
        both sides
    		 10 10
    Ray affected by study nodule
    Units: Subjects
        index
    		 2 2
        middle
    		 21 21
        ring
    		 78 78
        little
    		 39 39
    affected joint
    Units: Subjects
        metacarpophalangeal
    		 114 114
        proximal interphalangeal
    		 26 26
    Bilateral Dupuytren's disease
    Units: Subjects
        no
    		 65 65
        yes
    		 75 75
    Treatment for Dupuytren's disease in other hand
    Units: Subjects
        no
    		 109 109
        yes
    		 31 31
    Associated medical conditions
    Units: Subjects
        no
    		 72 72
        yes
    		 67 67
        missing
    		 1 1
    Plantar (Ledderhose) disease
    Units: Subjects
        no
    		 117 117
        yes
    		 22 22
        missing
    		 1 1
    Peyronie's disease
    Units: Subjects
        no
    		 134 134
        yes
    		 6 6
    Garrod's knuckle pads
    Units: Subjects
        no
    		 109 109
        yes
    		 31 31
    Family history (any relatives, self reported)
    Units: Subjects
        no
    		 75 75
        yes
    		 65 65
    Family history (1st Degree relatives)
    Units: Subjects
        no
    		 85 85
        yes
    		 55 55
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants analysed in their randomised groups with available outcome data. (Due to missing data for the primary endpoint (standard durometer) analysis multiple imputation by chained equations using predictive mean matching were used).

    Subject analysis sets values
    		 ITT
    Number of subjects
    140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.7 ( 10.0 )
    Gender categorical
    Units: Subjects
        Female
        Male
    Manual Occupation
    Units: Subjects
        Yes
        No
    Alcohol Consumption (units/week)
    Units: Subjects
        Non- Drinker
        up to 13
        14-35
        Over 35
    Current smoker
    Units: Subjects
        yes
        no
    Hand Dominance
    Units: Subjects
        right
        left
        Missing
    Epilepsy
    Units: Subjects
        no
        yes
    Liver Disease
    Units: Subjects
        no
    significant exposure to occupational vibration
    Units: Subjects
        no
        yes
    Previous significant trauma to affected hand
    Units: Subjects
        no
        yes
    Diabetes
    Units: Subjects
        no
        type 1
        type 2
    Frozen Shoulder
    Units: Subjects
        none
        right
        left
        both sides
    Ray affected by study nodule
    Units: Subjects
        index
        middle
        ring
        little
    affected joint
    Units: Subjects
        metacarpophalangeal
        proximal interphalangeal
    Bilateral Dupuytren's disease
    Units: Subjects
        no
        yes
    Treatment for Dupuytren's disease in other hand
    Units: Subjects
        no
        yes
    Associated medical conditions
    Units: Subjects
        no
        yes
        missing
    Plantar (Ledderhose) disease
    Units: Subjects
        no
        yes
        missing
    Peyronie's disease
    Units: Subjects
        no
        yes
    Garrod's knuckle pads
    Units: Subjects
        no
        yes
    Family history (any relatives, self reported)
    Units: Subjects
        no
        yes
    Family history (1st Degree relatives)
    Units: Subjects
        no
        yes

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab Baseline
    Reporting group description
    		 Anti-TNF Participants received the anti-TNF agent Adalimumab 40 mg in 0.4ml into the nodule at baseline, 3, 6 and 9 months after randomisation.

    Reporting group title
    Placebo Baseline
    Reporting group description
    		 Placebo Participants received an injection of saline (placebo) of equivalent volume at baseline, 3, 6 and 9 months after randomisation
    Reporting group title
    Adalimumab - 12 Months
    Reporting group description
    		 Anti-TNF Participants received the anti-TNF agent Adalimumab 40 mg in 0.4ml into the nodule at baseline, 3, 6 and 9 months after randomisation

    Reporting group title
    Placebo - 12 months
    Reporting group description
    		 Placebo Participants received an injection of saline (placebo) of equivalent volume at baseline, 3, 6 and 9 months after randomisation

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants analysed in their randomised groups with available outcome data. (Due to missing data for the primary endpoint (standard durometer) analysis multiple imputation by chained equations using predictive mean matching were used).

    Primary: Change in nodule hardness

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    End point title
    		 Change in nodule hardness
    End point description
    measured using a standard durometer Baseline were mean imputed, 12 Months: Adalimumab n=63, Saline n =64.
    End point type
    Primary
    End point timeframe
    Baseline to 12 Months
    End point values
    		 Adalimumab Baseline Placebo Baseline Adalimumab - 12 Months Placebo - 12 months ITT
    Number of subjects analysed
    70
    70
    59 [1]
    54 [2]
    113
    Units: Durometer Arbitrary Units
        arithmetic mean (standard deviation)
    63.2 ( 8.4 )
    61.4 ( 9.7 )
    58.1 ( 11.8 )
    61.2 ( 9.8 )
    59.56 ( 10.95 )
    Notes
    [1] - Measurements were available on 70 participants, the remainder were imputed
    [2] - Measurements were available on 54 participants, the remainder were imputed
    Statistical analysis title
    		 Primary analysis for the treatment effect
    Statistical analysis description
    Difference between adalimumab and saline adjusted for baseline values site and age.
    Comparison groups
    Adalimumab - 12 Months v Placebo - 12 months
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00024
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 -2.2

    Secondary: Nodule Size

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    End point title
    		 Nodule Size
    End point description
    Baseline were mean imputed, 12 months: Adalimumab n=61, Saline n =63.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 Months
    End point values
    		 Adalimumab Baseline Placebo Baseline Adalimumab - 12 Months Placebo - 12 months ITT
    Number of subjects analysed
    70
    70
    59
    54
    113
    Units: mm2
        arithmetic mean (standard deviation)
    27.7 ( 17.6 )
    32.2 ( 22.2 )
    21.8 ( 18.7 )
    35.9 ( 28.9 )
    30.0 ( 20.0 )
    Statistical analysis title
    		 treatment effect adjusted for site and age
    Comparison groups
    Adalimumab - 12 Months v Placebo - 12 months
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0025
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.8
         upper limit
    		 -2.9

    Secondary: Grip Strength

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    End point title
    		 Grip Strength
    End point description
    Baseline were mean imputed, 12 Months: Adalimumab n=63, Saline n =64.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Adalimumab Baseline Placebo Baseline Adalimumab - 12 Months Placebo - 12 months ITT
    Number of subjects analysed
    70
    70
    59
    54
    124
    Units: kg
        arithmetic mean (standard deviation)
    33.5 ( 10.7 )
    38.0 ( 12.1 )
    34.5 ( 10.7 )
    38.3 ( 11.9 )
    35.8 ( 11.7 )
    Statistical analysis title
    		 treatment effect adjusted for site and age
    Comparison groups
    Adalimumab Baseline v Placebo Baseline
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.5

    Secondary: Extension deficit of affected joint

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    End point title
    		 Extension deficit of affected joint
    End point description
    Overall active extension deficit of joint affected by treated nodule (degrees) Baseline were mean imputed, 12 Months: Adalimumab n=63, Saline n =65.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Adalimumab Baseline Placebo Baseline Adalimumab - 12 Months Placebo - 12 months ITT
    Number of subjects analysed
    70
    70
    59
    54
    140
    Units: degree
        arithmetic mean (standard deviation)
    -6.7 ( 15.9 )
    -3.9 ( 18.3 )
    -2.3 ( 20.4 )
    0.3 ( 25.1 )
    -5.3 ( 17.2 )
    Statistical analysis title
    		 treatment effect adjusted for site and age
    Comparison groups
    Adalimumab Baseline v Placebo Baseline
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 3.9
    Variability estimate
    Standard deviation

    Secondary: Participant reported outcomes

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    End point title
    		 Participant reported outcomes
    End point description
    MHQ - overall hand function Baseline were mean imputed, 12 Months: Adalimumab n=64, Saline n =66.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Adalimumab Baseline Placebo Baseline Adalimumab - 12 Months Placebo - 12 months ITT
    Number of subjects analysed
    70
    70
    59
    54
    140
    Units: Michigan Hand Questionnaire
        arithmetic mean (standard deviation)
    83.6 ( 14.9 )
    81.9 ( 16.8 )
    83.5 ( 16.1 )
    78.8 ( 16.0 )
    82.8 ( 15.8 )
    Statistical analysis title
    		 treatment effect adjusted for site and age
    Comparison groups
    Adalimumab Baseline v Placebo Baseline
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.13
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 7.5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 Months
    Adverse event reporting additional description
    AEs graded 3 and above occurring during the trial until 28 days after the last injection that were considered to be attributed to trial medication or the injection of the trial were reported. There were no AEs reported for the RIDD Trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2015
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No related SAEs were reported in the trial. One unrelated SAE (pericarditis [recorded as “chest infection”], saline arm, UK) was reported during the follow-up. No related grade 3+ AEs were reported during the follow-up for this trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2015
    Resubmission to MHRA: wording for abstinence section 7.2; unblinding procedure section 8.4. REC also sent pregnancy notification leaflet and consent form, and GP letter with PI details
    20 Jan 2016
    Participant burden in part 1 reduced by removing some secondary outcomes and visits. Grip strength, range of motion, MHQ and activity-most-restricted dropped. Added in measuring COL-3A1. Dropped visit one week after injection and one and four weeks after surgery. Also will not rate the scar and have removed mention of western blotting and histology. In part 2 there will be a blood sample at 12 months.
    29 Mar 2016
    To remove ´safety´ and ´run-in´ from the title. To allow dose cohorts to be done in different order and with lower or intermediate doses. To randomise via RRAMP not sealed envelopes for Part 1.
    17 May 2016
    To do RCT with 35mg into the nodule – not dependent on dose response results, To remove 1 week visit in RCT. Some modifications to inclusion/exclusion criteria. (protocol V7.0)
    17 Oct 2016
    New formulation of adalimumab to be used in Part 2 – impact on blinding and dosage (using 40mg instead of 35 mg). New formulation will be a cohort in Part 1. Changes to outcomes. (protocol V8.0)
    05 Jan 2018
    Protocol V9.0
    02 Jul 2018
    Amendment to protocol: IMP preparation section; to implement REC 3 contract rule required by REC in response to Amendment 12; change to mandate screening blood tests & increase max volume blood; removal of parenteral steroid exclusion criteria from part 2
    06 Nov 2018
    Change to target recruitment from 138 to maximum of 200. 7.3 Exclusion criteria - Removal of exclusion criteria: Part 2. Scheduled elective surgery or other procedures requiring general anaesthesia during the study Section 15.5 has been updated in line with GDPR.
    29 Aug 2019
    Updated RSI SmPC, Protocol amendment: increase of trial duration to 45 months; additional options for data collection; addition of information in case surgery occurs; changes to stats methods; increase of archiving period to 15 years; change to definition of RSI.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    COVID -19 pandemic caused the 18 month follow up for 76 participants to be delayed. Participants were sent the questionnaires to complete through the post and the follow up Case Report Forms were completed over the telephone meaning that that physical measures could not be taken. When lockdown restrictions were lifted the participants were invited back to the clinic to have physical measures taken and they complete the questionnaires once more.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data from the UK and NL could not be combined for analysis - different durometers were used. The NL data showed similar trends to those for the UK participants, but the small number of NL participants and missing data precluded statistical analyses.
    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.

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