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    Clinical Trial Results:
    ChAracterizing the Remission status in patients with Ulcerative Colitis treated by 5-ASA

    Summary
    EudraCT number
    		 2022-001683-10
    Trial protocol
    		 BE  
    Global end of trial date
    01 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2026
    First version publication date
    23 Jul 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIRD2022001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05992142
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIRD vzw (Belgian IBD Research & Development)
    Sponsor organisation address
    Leuvensesteenweg 643, Zaventem , Belgium, 1930
    Public contact
    Ingrid Arijs, BIRD vzw, +32 0499 31 70 05, ingrid.arijs@birdgroup.be
    Scientific contact
    Ingrid Arijs, BIRD vzw, +32 0499 31 70 05, ingrid.arijs@birdgroup.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
    01 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to describe the percentage of the different levels of remission (clinical, endoscopic, histological, biological), in UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit.
    Protection of trial subjects
    This clinical trial was conducted in compliance with the most recent version of the principles of the Declaration of Helsinki, the principles of Good Clinical Practice, and in accordance with all applicable regulatory requirements. The study was conducted on the basis of prior informed consent by the subjects to participate in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2023
    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: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    153
    From 65 to 84 years
    45
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between January 2023 and February 2024 a total of 205 patients were screened and 200 patients were enrolled (2 patients were excluded for analysis). First Patient In (FPI) was on 17Jan2023. Last Patient In (LPI) was on 23Jan2024. Last Patient Out (LPO) was on 1Feb2024.

    Pre-assignment
    Screening details
    		 UC patients (≥ 18 years) to whom 5-ASA has been prescribed for at least 6 months with dose stable for at least 2 weeks prior to inclusion. Patients were free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulators or IP) for at least 3 months. Patients were recruited during a routine visit.

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

    Arms
    Arm title
    		 Included patients for analysis
    Arm description
    		 -
    Arm type
    		 5-ASA

    Investigational medicinal product name
    5-ASA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Suppository, Rectal foam, Gastro-resistant granules, Rectal suspension, Gastro-resistant tablet, Granules
    Routes of administration
    Rectal use, Oral use
    Dosage and administration details
    5-ASA : All possible dosages and forms of administration (oral and/or rectal) prescribed in routine practice according to locally approved SmPC's - the study does not interfere with the therapeutic decisions of the treating physician at any point.

    Number of subjects in period 1 [1]
    		Included patients for analysis
    Started
    198
    Completed
    198
    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: 200 patients were enrolled, but only 198 patients were analysed. Two patients were excluded from analysis due to protocol violations.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 198 198
    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)
    		 151 151
        From 65-84 years
    		 45 45
        85 years and over
    		 2 2
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 50 (38 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 82 82
        Male
    		 116 116
    Smoking status
    Units: Subjects
        Smoker (> 1 cigarette/day)
    		 12 12
        Non-smoker
    		 113 113
        Former smoker
    		 73 73
    UC Montreal Classification
    Units: Subjects
        E1 (Ulcerative proctitis)
    		 73 73
        E2 (left-sided UC)
    		 87 87
        E3 (Extensive)
    		 13 13
        Pancolitis
    		 23 23
        Unknown
    		 2 2
    Disease duration
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 7 (3 to 15) -

    End points

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    End points reporting groups
    Reporting group title
    Included patients for analysis
    Reporting group description
    		 -

    Primary: the percentage of Complete Clinical Remission (CCR)

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    End point title
    		 the percentage of Complete Clinical Remission (CCR) [1]
    End point description
    Complete Clinical Remission is defined as PRO-2 = 0 and no bowel urgency (PRO-2 : Stool Frequency and Rectal Bleeding)
    End point type
    Primary
    End point timeframe
    Inclusion visit
    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: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: Percentage of subjects with CCR
    37
    No statistical analyses for this end point

    Primary: the percentage of Endoscopic Remission (ER)

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    End point title
    		 the percentage of Endoscopic Remission (ER) [2]
    End point description
    Endoscopic remission is defined by an endoscopic MAYO subscore (MES) of 0 or 1 and by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0 or 1
    End point type
    Primary
    End point timeframe
    Inclusion visit
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: Percentage of subjects with ER
    87
    No statistical analyses for this end point

    Primary: the percenage of Complete Endoscopic Remission (CER)

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    End point title
    		 the percenage of Complete Endoscopic Remission (CER) [3]
    End point description
    Complete endoscopic remission is defined as Mayo Endoscopic Subscore (MES) of 0 and by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0
    End point type
    Primary
    End point timeframe
    Inclusion visit
    Notes
    [3] - 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: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: Percentage of subjects with CER
    70
    No statistical analyses for this end point

    Primary: the percentage of Histological Remission (HR)

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    End point title
    		 the percentage of Histological Remission (HR) [4]
    End point description
    Histological remission is defined by the absence of any acute inflammatory activity on the biopsies according to the Geboes score, including Geboes 0-1
    End point type
    Primary
    End point timeframe
    Inclusion visit
    Notes
    [4] - 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: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    196
    Units: Percentage of subjects with HR
    80
    No statistical analyses for this end point

    Primary: the percentage of Biological Remission (BR)

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    End point title
    		 the percentage of Biological Remission (BR) [5]
    End point description
    Biological Remission is defined by FCP < 150 μg/g (FCP : Fecal Calprotectin)
    End point type
    Primary
    End point timeframe
    Inclusion visit
    Notes
    [5] - 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: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    194
    Units: Percentage of subjects with BR
    78
    No statistical analyses for this end point

    Primary: the percentage of Deep Remission (DR)

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    End point title
    		 the percentage of Deep Remission (DR) [6]
    End point description
    Deep Remission is defined as a combination of Complete Clinical Remission, Complete Endoscopic Remission and Histological Remission.
    End point type
    Primary
    End point timeframe
    Inclusion visit
    Notes
    [6] - 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: Only descriptive statistics were performed for this primary endpoint.
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    197
    Units: Percentage of subjects with DR
    24
    No statistical analyses for this end point

    Secondary: the proportion of prescription of different current 5-ASA regimens (administration form)

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    End point title
    		 the proportion of prescription of different current 5-ASA regimens (administration form)
    End point description
    to describe the prescription of different current 5-ASA regimens (administration form)
    End point type
    Secondary
    End point timeframe
    Inclusion visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: subjects
        Oral
    134
        Rectal
    19
        Combinded (oral + rectal)
    45
    No statistical analyses for this end point

    Secondary: the proportion of prescription of different current 5-ASA regimens (dose for oral monotherapy)

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    End point title
    		 the proportion of prescription of different current 5-ASA regimens (dose for oral monotherapy)
    End point description
    to describe the prescription of different current 5-ASA regimens (dose for oral monotherapy only)
    End point type
    Secondary
    End point timeframe
    Inclusion visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    134
    Units: subjects
        High dose (>3g/d)
    23
        Normal dose (2-3g/d)
    84
        Low dose (< 2g/d)
    27
    No statistical analyses for this end point

    Secondary: to describe adherence to 5-ASA treatment

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    End point title
    		 to describe adherence to 5-ASA treatment
    End point description
    Adherence to 5-ASA was assessed using the MARS-5 questionnaire (higher score represents higer adherence)
    End point type
    Secondary
    End point timeframe
    Inclusion visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: points
        median (inter-quartile range (Q1-Q3))
    24 (23 to 25)
    No statistical analyses for this end point

    Secondary: to describe Quality of Life (Symptoms)

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    End point title
    		 to describe Quality of Life (Symptoms)
    End point description
    Quality of life was evaluated using the Short-Health-Scale questionnaire, based on four questions using a visual analogue scale (with maximum score 100). For the question related to 'symptoms' higher scores mean more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Inclusion Visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: SHS Score
        median (inter-quartile range (Q1-Q3))
    10 (0 to 22)
    No statistical analyses for this end point

    Secondary: to describe Quality of Life (impact on decision making in patients lives)

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    End point title
    		 to describe Quality of Life (impact on decision making in patients lives)
    End point description
    Quality of life was evaluated using the Short-Health-Scale questionnaire, based on four questions using a visual analogue scale (with maximum score 100). For the question related to 'impact on decision-making in patients lives' higher scores mean more impact on daily activities.
    End point type
    Secondary
    End point timeframe
    Inclusion visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: SHS score
        median (inter-quartile range (Q1-Q3))
    1 (0 to 12)
    No statistical analyses for this end point

    Secondary: to describe Quality of Life (worry about the disease)

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    End point title
    		 to describe Quality of Life (worry about the disease)
    End point description
    Quality of life was evaluated using the Short-Health-Scale questionnaire, based on four questions using a visual analogue scale (with maximum score 100). For the question related to 'worry about the disease' higher scores mean more worry.
    End point type
    Secondary
    End point timeframe
    Inclusion Visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: SHS score
        median (inter-quartile range (Q1-Q3))
    10 (0 to 32)
    No statistical analyses for this end point

    Secondary: to describe quality of life (general well-being)

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    End point title
    		 to describe quality of life (general well-being)
    End point description
    Quality of life was evaluated using the Short-Health-Scale questionnaire, based on four questions using a visual analogue scale (with maximum score 100). For the question related to 'general well-being' with lower scores mean better well-being.
    End point type
    Secondary
    End point timeframe
    Inclusion visit
    End point values
    		 Included patients for analysis
    Number of subjects analysed
    198
    Units: SHS score
        median (inter-quartile range (Q1-Q3))
    11 (0 to 30)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From signature of informed consent form up to completion of the study for that participant. For SAE's up to 30 days after the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    UC patients
    Reporting group description
    		 -

    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: Only 3 adverse events occurred (in 3 patients). Therefore none of the adverse event meet the criterium of 5%.
    Serious adverse events
    		 UC patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 200 (0.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Infectious syndrome
         subjects affected / exposed
    1 / 200 (0.50%)
         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
    		 UC patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2023
    - Updated timelines for fecal calprotectin assessment and clarification on the conditions for the windows of the fecal calprotectin assessment and sigmoidoscopy - addition of possibility to capture routine biochemistry/fecal calprotectin results from maximum 1 month prior to screening/inclusion visit on the condition 5-ASA treatment remained stable in between. - Update duration of study for a patient (based on updated timeline for fecal calprotectin assessment) - Updated exclusion criteria to specify patients on UC-approved medication used for another indication should be excluded - Alignment between primary objective and primary endpoint with addition of biological remission - Additional clarifications for some study procedures - Changes to the Physician's questionnaire to capture information on potential change of current 5-ASA treatment

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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