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    Clinical Trial Results:
    Abatacept Bone Effects in Psoriatic Arthritis with Bone Biomarker – ABEPSA_BB

    Summary
    EudraCT number
    		 2017-002793-39
    Trial protocol
    		 DE  
    Global end of trial date
    16 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2024
    First version publication date
    19 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0451
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Maximiliansplatz 2, Erlangen, Germany, 91054
    Public contact
    Medizinische Klinik 3, Universitätsklinikum Erlangen, arnd.kleyer@extern.uk-erlangen.de
    Scientific contact
    Medizinische Klinik 3, Universitätsklinikum Erlangen, arnd.kleyer@extern.uk-erlangen.de
    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
    03 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effects of abatacept on erosive bone changes in patients with PsA for up to 24 weeks
    Protection of trial subjects
    To limit the risk for side effects, abatacept was used according to the SmPC, furthermore vigorous inclusion and exclusion criteria as well as study visits over time did monitor the patients on drug
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2018
    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
    Germany: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    11
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient recruitment was performed in the outpatient and inpatient ward of the department of Internal Medicine 3, Universitätsklinikum Erlangen

    Pre-assignment
    Screening details
    		 Diagnosis of psoriasis arthritis acc. to the CASPAR criteria with active arthritis (> 2 swollen and tender joints) and at least 1 erosion at the MCP joint 2 o3 3 in imaging; indication for treatment with abatacept acc. to its SmPC

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment abatacept
    Arm description
    		 treatment duration 24 weeks, 125 mg s.c. once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125 mg s.c. once weekly for 24 weeks

    Number of subjects in period 1
    		Treatment abatacept
    Started
    15
    Completed
    8
    Not completed
    7
         Physician decision
    1
         Adverse event, non-fatal
    1
         Lack of efficacy
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 15 15
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 7 7
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (full range (min-max))
    		 30.68 (25.62 to 45.49) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment abatacept
    Reporting group description
    		 treatment duration 24 weeks, 125 mg s.c. once weekly

    Primary: Change in bone erosion volume at the second and third MCP joint measured by HR-pQCT

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    End point title
    		 Change in bone erosion volume at the second and third MCP joint measured by HR-pQCT [1]
    End point description
    End point type
    Primary
    End point timeframe
    week 24 compared to baseline
    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: No statistical analyses planned (descriptive, only CI)
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    7 [2]
    Units: cubic millimeter
        arithmetic mean (confidence interval 95%)
    0.71 (-1.53 to 2.95)
    Notes
    [2] - 2 early terminations, 5 non-responder, 1 non assessable due to destruction of the MCP joints
    No statistical analyses for this end point

    Secondary: Number of new erosions at second and thirt MCP joint at week 24 using HR-pQCT

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    End point title
    		 Number of new erosions at second and thirt MCP joint at week 24 using HR-pQCT
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    7 [3]
    Units: number of erosions
    0
    Notes
    [3] - 2 early terminations, 5 non-responder, 1 non assessable due to destruction of the MCP joints
    No statistical analyses for this end point

    Secondary: Number of new osteophytes in MCP joints at week 24 using HR-pQCT

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    End point title
    		 Number of new osteophytes in MCP joints at week 24 using HR-pQCT
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    7 [4]
    Units: number of new osteophytes
    0
    Notes
    [4] - 2 early terminations, 5 non-responder, 1 non assessable due to destruction of the MCP joints
    No statistical analyses for this end point

    Secondary: Number of new erosions at week 24 using hand MRI

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    End point title
    		 Number of new erosions at week 24 using hand MRI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [5]
    Units: number of erosions
    1
    Notes
    [5] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in tenosynovitis score using hand MRI

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    End point title
    		 Change in tenosynovitis score using hand MRI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [6]
    Units: none
        arithmetic mean (confidence interval 95%)
    -1.22 (-2.79 to 0.34)
    Notes
    [6] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in PSAMRIS using hand MRI

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    End point title
    		 Change in PSAMRIS using hand MRI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [7]
    Units: none
        arithmetic mean (confidence interval 95%)
    2.66 (-1.01 to 6.34)
    Notes
    [7] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in synovitis score using hand MRI

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    End point title
    		 Change in synovitis score using hand MRI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [8]
    Units: none
        arithmetic mean (confidence interval 95%)
    1.99 (0.54 to 3.44)
    Notes
    [8] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in DAS28 (ESR)

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    End point title
    		 Change in DAS28 (ESR)
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [9]
    Units: none
        arithmetic mean (confidence interval 95%)
    -1.93 (-2.44 to -1.41)
    Notes
    [9] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in DAPSA

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    End point title
    		 Change in DAPSA
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [10]
    Units: none
        arithmetic mean (confidence interval 95%)
    -18.6 (-24.48 to -12.73)
    Notes
    [10] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in HAQ-DI

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    End point title
    		 Change in HAQ-DI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [11]
    Units: none
        arithmetic mean (confidence interval 95%)
    -0.12 (-0.43 to 0.18)
    Notes
    [11] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in SPARCC

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    End point title
    		 Change in SPARCC
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [12]
    Units: none
        arithmetic mean (confidence interval 95%)
    -1.15 (-2.4 to 0.09)
    Notes
    [12] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in PSAID

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    End point title
    		 Change in PSAID
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [13]
    Units: none
        arithmetic mean (confidence interval 95%)
    -0.79 (-2.04 to 0.46)
    Notes
    [13] - 2 Early terminations
    No statistical analyses for this end point

    Secondary: Change in PASI

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    End point title
    		 Change in PASI
    End point description
    End point type
    Secondary
    End point timeframe
    week 24 compared to baseline
    End point values
    		 Treatment abatacept
    Number of subjects analysed
    13 [14]
    Units: none
        arithmetic mean (confidence interval 95%)
    0.03 (-2.79 to 2.85)
    Notes
    [14] - 2 Early terminations
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    V1 (enrolment) until V5 (EoS, week 28)
    Adverse event reporting additional description
    AE reporting continuously during the treatment period and for a minimum of 4 weeks after the last IMP administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 all subjects treated with at least 1 dose of IMP

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
    Investigations
    Blood glucose abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Prostatic specific antigen abnormal
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Immunisation reaction
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pustular psoriasis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2019
    Change Investigator, Update SmPC
    16 Apr 2020
    Additional Inclusion criterion reg. wash out times for pre-treatment with b/tsDMARDs; SF-36 questionnaire deleted
    29 Dec 2020
    Inclusion/Exclusion criteria specified (localisation of erosions; cDMARD intolerance etc.)

    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.
    Early termination due to poor recruitment; number of subjects limited
    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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