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    Clinical Trial Results:
    TapERA: Maintaining remission in RA while tapering Etanercept.

    Summary
    EudraCT number
    		 2012-004631-22
    Trial protocol
    		 BE  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Apr 2021
    First version publication date
    16 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TapERA2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    herestraat 49, Leuven, Belgium, 3000
    Public contact
    Patrick Verschueren, University Hospitals Leuven, 32 16342541, patrick.verschueren@uzleuven.be
    Scientific contact
    Patrick Verschueren, University Hospitals Leuven, 32 16342541, patrick.verschueren@uzleuven.be
    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
    09 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the current study is to explore the potential of a dose reduction of Etanercept on safety and persisting remission in RA patients.
    Protection of trial subjects
    Patients were pseudonymised. Informed consent was obtained. Patient were re-escalated to weekly Etanercept use in case of loss of remission. Medication (Etanercept) used in this trial was within the marketing authorisation. Protocol obtained ethics committee approval. .
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2013
    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: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    54
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 66 eligible patients were recruited between October 2012 and December 2014. There were patients included in 6 Belgian rheumatology centers (2 university hospitals, 3 general hospitals and 1 private practice)

    Pre-assignment
    Screening details
    		 There were 73 patients screened . Of these screened patients 66 were included in the trial. 7 patients did not fulfill the eligibility criteria (e.g. no sustained remission for 6 months based on DAS28CRP/ESR) .

    Pre-assignment period milestones
    Number of subjects started
    		 73 [1]
    Number of subjects completed
    		 66

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 7
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 7 patients not included due to protocol violation (not meeting inclusion criteria)
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Weekly Etanercept
    Arm description
    		 patients continue their weekly 50 mg etanercept treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    IMP-228/2014
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    etanercept 50 mg subcutaneously weekly

    Arm title
    		 Every other week Etanercept
    Arm description
    		 Etanercept 50 mg weekly every other week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    IMP-228/2014
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    etanercept 50 mg subcutaneously every other week

    Number of subjects in period 1
    		Weekly Etanercept Every other week Etanercept
    Started
    34
    32
    Completed
    33
    31
    Not completed
    1
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Weekly Etanercept
    Reporting group description
    		 patients continue their weekly 50 mg etanercept treatment

    Reporting group title
    Every other week Etanercept
    Reporting group description
    		 Etanercept 50 mg weekly every other week.

    Reporting group values
    		 Weekly Etanercept Every other week Etanercept Total
    Number of subjects
    		 34 32 66
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 27 27 54
        From 65-84 years
    		 7 5 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 56.0 (48.0 to 64.0) 52.5 (45.5 to 60.5) -
    Gender categorical
    Units: Subjects
        Female
    		 20 25 45
        Male
    		 14 7 21
    disease duration
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 15.0 (9.0 to 19.0) 13.5 (7.0 to 20.5) -
    DAS28CRP
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 1.9 (1.4 to 2.4) 1.7 (1.3 to 2.1) -

    End points

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    End points reporting groups
    Reporting group title
    Weekly Etanercept
    Reporting group description
    		 patients continue their weekly 50 mg etanercept treatment

    Reporting group title
    Every other week Etanercept
    Reporting group description
    		 Etanercept 50 mg weekly every other week.

    Subject analysis set title
    Proportion of patients maintaining remission for 6 months
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Proportions of patients maintaining remission for 6 months based on the DAS28-CRP below 2.6. Proportions were compared using the Chi-squared test.

    Primary: Proportion maintaining remission for 6 months

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    End point title
    		 Proportion maintaining remission for 6 months
    End point description
    proportion of patients maintaining remission (DAS28CRP<2.6) at every study visit until month 6.
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Weekly Etanercept Every other week Etanercept Proportion of patients maintaining remission for 6 months
    Number of subjects analysed
    34
    32
    66
    Units: number of patients
    26
    19
    45
    Statistical analysis title
    		 Chi-squared
    Comparison groups
    Weekly Etanercept v Every other week Etanercept
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: proportion of patients maintaining remission for 12 months

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    End point title
    		 proportion of patients maintaining remission for 12 months
    End point description
    Proportion of patients maintaining remission for 12 months based on the DAS28-CRP below 2.6. Proportions were compared using the Chi-squared test.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Weekly Etanercept Every other week Etanercept
    Number of subjects analysed
    34
    32
    Units: number of patients
    21
    14
    Statistical analysis title
    		 Chi squared
    Comparison groups
    Weekly Etanercept v Every other week Etanercept
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    the entire duration of the trial: 12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    etanercept weekly
    Reporting group description
    		 -

    Reporting group title
    etanercept every other week
    Reporting group description
    		 -

    Serious adverse events
    		 etanercept weekly etanercept every other week
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 34 (8.82%)
    6 / 32 (18.75%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Knee arthroplasty
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Therapy change
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 etanercept weekly etanercept every other week
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 34 (52.94%)
    15 / 32 (46.88%)
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Intermittent claudication
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Bunion operation
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Skin lesion removal
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Injection site reaction
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Calcinosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Vocal cord disorder
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Muscle rupture
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Radius fracture
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Myelofibrosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Barrett's oesophagus
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastric disorder
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema asteatotic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Tendon disorder
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 34 (0.00%)
    3 / 32 (9.38%)
         occurrences all number
    0
    3
    Osteoporosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Foot deformity
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 32 (9.38%)
         occurrences all number
    2
    3
    Cellulitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 32 (9.38%)
         occurrences all number
    1
    3
    Pneumonia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Wound infection
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    lower sample size than expected was included in the trial and therfore the power of the trial was not achieved.
    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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