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    Clinical Trial Results:
    Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design (Analyses of patients who receive tumor necrosis factor inhibitor drugs (TNFi))

    Summary
    EudraCT number
    		 2012-005275-14
    Trial protocol
    		 NO  
    Global end of trial date
    23 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2023
    First version publication date
    19 Nov 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DIA2012-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01881308
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Diakonhjemmet Hospital AS
    Sponsor organisation address
    Diakonveien 12, Oslo, Norway, 0370
    Public contact
    Principal Investigator, Diakonhjemmet Hospital AS, +47 22451500, e.a.haavardsholm@medisin.uio.no
    Scientific contact
    Principal Investigator, Diakonhjemmet Hospital AS, +47 22451500, e.a.haavardsholm@medisin.uio.no
    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
    16 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of tapering and withdrawal of TNFi on disease activity in RA patients in sustained remission.
    Protection of trial subjects
    Each patient was instructed to contact the investigator immediately if they showed signs or symptoms they perceived as serious adverse events. If the patient suspected a flare in disease activity, he or she was instructed to contact the study site immediately and they should be seen within a week. Patients had the right to withdraw from the study at any time for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Dec 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 99
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    63
    From 65 to 84 years
    30
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment of patients took place at nine hospital-based rheumatology practices in Norway

    Pre-assignment
    Screening details
    		 Adult men and women with RA who had been in sustained remission for at least 1 year on stable TNFi medication were screened by a study investigator (physician) for inclusion into the study.

    Period 1
    Period 1 title
    intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tapering of TNFi
    Arm description
    		 tapering of TNFi treatment. the TNFi was reduced to half dose for 4 months, and withdrawn at the 4-month visit if the patient was still in remission.
    Arm type
    		 Experimental

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector, Solution for injection in pre-filled pen
    Routes of administration
    Injection
    Dosage and administration details
    standard full dosage: 50 mg weekly subcutanous injection 1/2 dosage regime 25 mg weekly subcutanous injection after 4 months discontinued intervention if still in remission.

    Investigational medicinal product name
    certolizumab pegol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard dose: 200mg bi-weekly injection. 1/2 dosage regime: 200 mg every 4 week Discontinuation of intervention at 4 months if still in remission.

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard dosage: 50 mg subcutanous injection every 4 weeks. 1/2 dosage regimen: 50 mg subcutanous injection every 8 weeks. Discontinuation after 4 months if still in remission

    Investigational medicinal product name
    infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Standard full dosage: 3-5 mg/kg intravenous administration every 8 weeks 1/2 dosage regimen: 1.5-3 mg/kg intravenous administration every 8 weeks Discontinuation at the 4 month visit if still in remission

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard full dosage: 40 mg subcutanous injection bi-weekly 1/2 dosage regimen: 40 mg subcutanous injection every 4 weeks Discontinuation at the 4 month visit if still in remission

    Arm title
    		 Stable TNFi
    Arm description
    		 patients randomized to continue stable TNFi treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    certolizumab pegol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard dose: 200mg bi-weekly injection.

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector, Solution for injection in pre-filled pen
    Routes of administration
    Injection
    Dosage and administration details
    standard full dosage: 50 mg weekly subcutanous injection

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard dosage: 50 mg subcutanous injection every 4 weeks.

    Investigational medicinal product name
    infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Standard full dosage: 3-5 mg/kg intravenous administration every 8 weeks

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Standard full dosage: 40 mg subcutanous injection bi-weekly

    Number of subjects in period 1 [1]
    		Tapering of TNFi Stable TNFi
    Started
    47
    45
    Completed
    43
    41
    Not completed
    4
    4
         patients decision
    1
    1
         Adverse event, non-fatal
    -
    3
         Protocol deviation
    3
    -
    Notes
    [1] - The number of subjects reported to be in the baseline 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 subjects were randomised, but did not receive the allocated treatment strategy (2 subjects decided to withdraw from the study, and 5 subjects did not meet the inclusion criteria (screening failures)). These were not included in the analyses, in accordance with the protocol and the statistical analysis plan.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tapering of TNFi
    Reporting group description
    		 tapering of TNFi treatment. the TNFi was reduced to half dose for 4 months, and withdrawn at the 4-month visit if the patient was still in remission.

    Reporting group title
    Stable TNFi
    Reporting group description
    		 patients randomized to continue stable TNFi treatment.

    Reporting group values
    		 Tapering of TNFi Stable TNFi Total
    Number of subjects
    		 47 45 92
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.6 ± 12.6 57.4 ± 10.7 -
    Gender categorical
    Units: Subjects
        Female
    		 25 30 55
        Male
    		 22 15 37
    Anticitrullinated peptide
    Units: Subjects
        Positive
    		 36 35 71
        Negative
    		 11 10 21
    Rheumatoid factor
    Units: Subjects
        Positive
    		 32 28 60
        Negative
    		 15 17 32
    ACR EULAR Boolean remission
    Units: Subjects
        Yes
    		 38 30 68
        No
    		 9 15 24
    Tumor necrosis factor inhibitor
    Units: Subjects
        Etanercept
    		 20 20 40
        Certoizumab pegol
    		 14 15 29
        Golimumab
    		 1 4 5
        Infliximab
    		 9 0 9
        Adalimumab
    		 3 6 9
    Co-medication with csDMARDs
    Units: Subjects
        Yes
    		 42 41 83
        No
    		 5 4 9
    Co-medication with methotrexate
    Units: Subjects
        Yes
    		 38 38 76
        No
    		 9 7 16
    Time since first swollen joint
    Units: year
        arithmetic mean (standard deviation)
    		 11.9 ± 6.9 10.0 ± 7.2 -
    Disease activity Score (DAS)
    DAS (range 0-10) includes a 44 swollen joint count, assessment of tender joints by ritchie articular index, the ESR and patients global assessment of disease activity on a VAS 0-100 mm.
    Units: score 0-10
        arithmetic mean (standard deviation)
    		 0.8 ± 0.3 0.9 ± 0.4 -
    Swollen joint count
    The swollen joint count is the number of swollen joints out of 44 joints assessed
    Units: 0-44
        arithmetic mean (standard deviation)
    		 0.0 ± 0.0 0.0 ± 0.0 -
    Tender joint count (Ritchie Articular Index)
    The tender joint count is performed by the Ritchie Articular Index assessing tenderness of 26 joint regions, the index ranges 0-3 for individual measures and the sum 0-78 overall
    Units: 0-78
        arithmetic mean (standard deviation)
    		 0.1 ± 0.2 0.2 ± 0.5 -
    ESR
    Erytrocyte sedimentation rate mm/hour
    Units: mm/hour
        median (inter-quartile range (Q1-Q3))
    		 7 (5 to 14) 8 (5 to 15) -
    CRP
    C-reactive protein
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    		 0.1 (0.1 to 0.3) 0.1 (0.1 to 0.2) -
    Patient's global assessment
    self-reported overall assessment of disease activity with use of a VAS range 0-100 mm
    Units: 0-100 mm
        median (inter-quartile range (Q1-Q3))
    		 3 (1 to 12) 2 (1 to 12) -
    Physician's global assessment
    self-reported overall assessment of disease activity with use of a VAS range 0-100 mm
    Units: 0-100 mm
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 2) 0 (0 to 2) -
    PROMIS physical function
    PROMIS 20 item short form range 0-100, with scores lower than 50 indicating disability worse than average
    Units: range 0-100
        median (inter-quartile range (Q1-Q3))
    		 52.6 (49.0 to 62.5) 51.2 (44.2 to 62.5) -
    Total van der Heijde modified Sharp score
    This method assesses erosions in 16 of each hand and 6 joints of each foot, and joint space narrowing in 15 joints for each hand as well as six joints of each foot. This gives scores for erosions on a scale of 0-280 and joint-space narrowing on a scale of 0-168, thus the total van der Heijde Sharp score range is 0-448
    Units: range 0-448
        median (inter-quartile range (Q1-Q3))
    		 6.5 (1.5 to 12) 5 (1.5 to 13.5) -
    Total power Doppler SIgnal Score
    Ultrasound examination was performed using a 0-3 semiquantitative scoring system for both grey scale and power Doppler in 32 joint
    Units: range 0-96
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 0) -
    Total Grey Scale Score
    Ultrasound examination was performed using a 0-3 semiquantitative scoring system for both grey scale and power Doppler in 32 joint
    Units: range 0-96
        median (inter-quartile range (Q1-Q3))
    		 1 (0 to 3) 1 (0 to 3) -
    Subject analysis sets

    Subject analysis set title
    Tapering TNFi (Per protocol set)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all randomised patients meeting the study entry criteria and with no protocol deviations affecting the treatment efficacy

    Subject analysis set title
    Stable TNFi (per protocol set)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all randomised patients meeting the study entry criteria and with no protocol deviations affecting the treatment efficacy

    Subject analysis sets values
    		 Tapering TNFi (Per protocol set) Stable TNFi (per protocol set)
    Number of subjects
    43
    41
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    57.3 ± 13
    57.4 ± 11.2
    Gender categorical
    Units: Subjects
        Female
    23
    26
        Male
    20
    15
    Anticitrullinated peptide
    Units: Subjects
        Positive
    33
    33
        Negative
    10
    8
    Rheumatoid factor
    Units: Subjects
        Positive
    30
    25
        Negative
    13
    16
    ACR EULAR Boolean remission
    Units: Subjects
        Yes
    36
    27
        No
    7
    14
    Tumor necrosis factor inhibitor
    Units: Subjects
        Etanercept
    19
    18
        Certoizumab pegol
    12
    15
        Golimumab
    1
    4
        Infliximab
    9
    0
        Adalimumab
    2
    4
    Co-medication with csDMARDs
    Units: Subjects
        Yes
    38
    38
        No
    5
    3
    Co-medication with methotrexate
    Units: Subjects
        Yes
    34
    35
        No
    9
    6
    Time since first swollen joint
    Units: year
        arithmetic mean (standard deviation)
    11.7 ± 7.0
    9.4 ± 6.6
    Disease activity Score (DAS)
    DAS (range 0-10) includes a 44 swollen joint count, assessment of tender joints by ritchie articular index, the ESR and patients global assessment of disease activity on a VAS 0-100 mm.
    Units: score 0-10
        arithmetic mean (standard deviation)
    0.8 ± 0.3
    0.9 ± 0.4
    Swollen joint count
    The swollen joint count is the number of swollen joints out of 44 joints assessed
    Units: 0-44
        arithmetic mean (standard deviation)
    0.0 ± 0.0
    0.0 ± 0.0
    Tender joint count (Ritchie Articular Index)
    The tender joint count is performed by the Ritchie Articular Index assessing tenderness of 26 joint regions, the index ranges 0-3 for individual measures and the sum 0-78 overall
    Units: 0-78
        arithmetic mean (standard deviation)
    0.1 ± 0.3
    0.2 ± 0.5
    ESR
    Erytrocyte sedimentation rate mm/hour
    Units: mm/hour
        median (inter-quartile range (Q1-Q3))
    7.0 (5 to 13)
    8 (5 to 15)
    CRP
    C-reactive protein
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    0.1 (0.1 to 0.3)
    0.1 (0.1 to 0.2)
    Patient's global assessment
    self-reported overall assessment of disease activity with use of a VAS range 0-100 mm
    Units: 0-100 mm
        median (inter-quartile range (Q1-Q3))
    3 (1 to 9)
    2 (1 to 12)
    Physician's global assessment
    self-reported overall assessment of disease activity with use of a VAS range 0-100 mm
    Units: 0-100 mm
        median (inter-quartile range (Q1-Q3))
    0 (0 to 2)
    0 (0 to 2)
    PROMIS physical function
    PROMIS 20 item short form range 0-100, with scores lower than 50 indicating disability worse than average
    Units: range 0-100
        median (inter-quartile range (Q1-Q3))
    52.6 (49.0 to 62.5)
    51.2 (44.2 to 62.5)
    Total van der Heijde modified Sharp score
    This method assesses erosions in 16 of each hand and 6 joints of each foot, and joint space narrowing in 15 joints for each hand as well as six joints of each foot. This gives scores for erosions on a scale of 0-280 and joint-space narrowing on a scale of 0-168, thus the total van der Heijde Sharp score range is 0-448
    Units: range 0-448
        median (inter-quartile range (Q1-Q3))
    6.5 (1.5 to 12.5)
    5.0 (1.5 to 13.0)
    Total power Doppler SIgnal Score
    Ultrasound examination was performed using a 0-3 semiquantitative scoring system for both grey scale and power Doppler in 32 joint
    Units: range 0-96
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Total Grey Scale Score
    Ultrasound examination was performed using a 0-3 semiquantitative scoring system for both grey scale and power Doppler in 32 joint
    Units: range 0-96
        median (inter-quartile range (Q1-Q3))
    1 (0 to 3)
    1 (0 to 3)

    End points

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    End points reporting groups
    Reporting group title
    Tapering of TNFi
    Reporting group description
    		 tapering of TNFi treatment. the TNFi was reduced to half dose for 4 months, and withdrawn at the 4-month visit if the patient was still in remission.

    Reporting group title
    Stable TNFi
    Reporting group description
    		 patients randomized to continue stable TNFi treatment.

    Subject analysis set title
    Tapering TNFi (Per protocol set)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all randomised patients meeting the study entry criteria and with no protocol deviations affecting the treatment efficacy

    Subject analysis set title
    Stable TNFi (per protocol set)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all randomised patients meeting the study entry criteria and with no protocol deviations affecting the treatment efficacy

    Primary: Flare rate

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    End point title
    		 Flare rate
    End point description
    Flare rate in tapered versus stable TNFi treatment. Flare was defined as a combination of DAS above cut-off for remission (1.6), a change in DAS of at least 0.6, and at least two swollen joints, or that both the treating physician and the patient agreed that a clinically significant flare had occured.
    End point type
    Primary
    End point timeframe
    0-12 months
    End point values
    		 Tapering of TNFi Stable TNFi Tapering TNFi (Per protocol set) Stable TNFi (per protocol set)
    Number of subjects analysed
    47
    45
    43
    41
    Units: flare
        yes
    28
    4
    27
    2
        no
    19
    41
    16
    39
    Statistical analysis title
    		 Difference in flare rate
    Statistical analysis description
    Assess the non-inferiority of tapered TNFi therapy comapred to stable TNFi therapy.
    Comparison groups
    Tapering TNFi (Per protocol set) v Stable TNFi (per protocol set)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk difference (RD)
    Point estimate
    57.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42
         upper limit
    		 73.8

    Secondary: Progression of radiographic joint damage

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    End point title
    		 Progression of radiographic joint damage
    End point description
    Progression of radiographic joint damage was defined as a change of >=1 unit per year
    End point type
    Secondary
    End point timeframe
    0-12 months
    End point values
    		 Tapering TNFi (Per protocol set) Stable TNFi (per protocol set)
    Number of subjects analysed
    42
    40
    Units: van der Heijde Sharp score
    number (not applicable)
        yes
    8
    4
        no
    34
    36
    No statistical analyses for this end point

    Secondary: Disease activity remission (DAS)

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    End point title
    		 Disease activity remission (DAS)
    End point description
    Rate of Disease activity (DAS) remission at 12 months
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Tapering TNFi (Per protocol set) Stable TNFi (per protocol set)
    Number of subjects analysed
    42
    40
    Units: remission
        yes
    37
    34
        no
    42
    6
    No statistical analyses for this end point

    Secondary: DAS at time of flare

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    End point title
    		 DAS at time of flare
    End point description
    Disease activity score at time of flare
    End point type
    Secondary
    End point timeframe
    time of flare
    End point values
    		 Tapering TNFi (Per protocol set) Stable TNFi (per protocol set)
    Number of subjects analysed
    25
    2
    Units: disease activity score 0-10
        median (standard error)
    2.2 ± 0.8
    1.9 ± 0.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    V21.1E
    Reporting groups
    Reporting group title
    Tapering of TNFi
    Reporting group description
    		 tapering of TNFi treatment. the TNFi was reduced to half dose for 4 months, and withdrawn at the 4-month visit if the patient was still in remission.

    Reporting group title
    Stable TNFi
    Reporting group description
    		 patients randomized to continue stable TNFi treatment.

    Serious adverse events
    		 Tapering of TNFi Stable TNFi
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 45 (4.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Falling down
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Rheumatoid vasculitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Heart attack
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block third degree
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tapering of TNFi Stable TNFi
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 47 (14.89%)
    5 / 45 (11.11%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    3
    Infections and infestations
    common cold
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 45 (4.44%)
         occurrences all number
    7
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2017
    The initial protocol required symptom duration less than 5 years; this was removed in a protocol update. The reasons included that some patients could not be included due to difficulties in determining symptom duration, and that the protocol update increased the number of patients eligible for enrolment.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    04 Jan 2019
    Patient recruitment was closed before the target number had been reached due to a lower inclusion rate than aticipated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37607809
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