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    Clinical Trial Results:
    Alemtuzumab for ANCA-Associated Refractory Vasculitis - A study of safety and efficacy (ALEVIATE).

    Summary
    EudraCT number
    		 2009-017087-17
    Trial protocol
    		 GB  
    Global end of trial date
    29 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AL7.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Trust
    Sponsor organisation address
    Hills Road, Cambridge, United Kingdom, CB2 0QQ
    Public contact
    Prof David Jayne, Cambridge University Hospitals NHS Trust & University of Cambridge, 01223 748062,
    Scientific contact
    Prof David Jayne, Cambridge University Hospitals NHS Trust & University of Cambridge, 01223 748062,
    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
    15 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The trial objectives are to assess the efficacy (vasculitis response at 6 months) and safety (proportion of patients with severe adverse events) of alemtuzumab in refractory or relapsing primary systemic vasculitis.
    Protection of trial subjects
    Alemtuzumab is a monoclonal antibody that depletes lymphocytes. It is known to be associated with increased risk of infections and new onset autoimmunity (especially thyroid). All patients that received alemtuzumab in this trial are followed up closely at Addenbrookes hospital for the development of new-onset autoimmunity. Patients, as well as GPs have been appraised of these risks. We are in the process of obtaining ethical approval to follow these patients long-term.
    Background therapy
    		 All other immunosuppressive & immunomodulator therapies are stopped before entering the trial and receiving alemtuzumab. Oral glucocorticoids are allowed.
    Evidence for comparator
    		 In this phase II trial, two dosing regimens of alemtuzumab were compared to establish if lower dose is as efficacious as higher dose and if it is associated with better safety. There is no prior randomised contril trial literature to support one dose over the other.
    Actual start date of recruitment
    07 Apr 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Scientific research
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 24 patients were recruited from a single center (Addenbrookes hospital, Cambridge, UK) over a period of 7 years (11/4/2011 to 29/5/2018). Recruitment was delayed due to small patient pool from which to recruit from, unavailability of the drug for a period as the company withdrew the license for rebranding purposes.

    Pre-assignment
    Screening details
    		 Patients were evaluated by trial investigators to ensure they met all the inclusion criteria and none of the exclusion criteria as detailed in the trial protocol. A total of XX patients were screened for inclusion into the trial.

    Period 1
    Period 1 title
    Consent
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 30mg.

    Arm title
    		 High dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 60mg.

    Number of subjects in period 1
    		Low dose arm High dose arm
    Started
    13
    11
    Completed
    13
    10
    Not completed
    0
    1
         Physician decision
    -
    1
    Period 2
    Period 2 title
    Baseline
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 30mg.

    Arm title
    		 High dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 60mg.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: A new period called consent has been created as one of the patients in the high dose group after consenting was withdrawn straight away even before receiving IMP due to the physician's decision. This patient is not included in further analysis.
    Number of subjects in period 2 [2]
    		Low dose arm High dose arm
    Started
    13
    10
    Completed
    13
    10
    Notes
    [2] - 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: As above
    Period 3
    Period 3 title
    Post-treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 30mg.

    Arm title
    		 High dose arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30mg of alemtuzumab administered intravenously over a period of 4 to 8 hours. The dose is repeated next day. Total alemtuzumab dose 60mg.

    Number of subjects in period 3
    		Low dose arm High dose arm
    Started
    13
    10
    Completed
    10
    7
    Not completed
    3
    3
         Lack of efficacy
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low dose arm
    Reporting group description
    		 -

    Reporting group title
    High dose arm
    Reporting group description
    		 -

    Reporting group values
    		 Low dose arm High dose arm Total
    Number of subjects
    		 13 10 23
    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
    Age in years
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 35 (25 to 46.1) 41 (33 to 44) -
    Gender categorical
    Units: Subjects
        Female
    		 7 8 15
        Male
    		 6 2 8
    Disease
    Disease category
    Units: Subjects
        ANCA associated vasculitis
    		 6 6 12
        Behcet's disease
    		 7 4 11
    ANCA specificity
    ANCA subtype
    Units: Subjects
        PR3
    		 4 3 7
        MPO
    		 1 0 1
        ANCA negative
    		 8 7 15
    BVAS/WG score
    Disease activity score at entry
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 4 (4 to 6) 4.5 (4 to 5) -
    Prior disease duration
    Disease duration prior to enrolment into trial
    Units: months
        median (inter-quartile range (Q1-Q3))
    		 76 (52 to 115) 51 (40 to 68.5) -

    End points

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    End points reporting groups
    Reporting group title
    Low dose arm
    Reporting group description
    		 -

    Reporting group title
    High dose arm
    Reporting group description
    		 -
    Reporting group title
    Low dose arm
    Reporting group description
    		 -

    Reporting group title
    High dose arm
    Reporting group description
    		 -
    Reporting group title
    Low dose arm
    Reporting group description
    		 -

    Reporting group title
    High dose arm
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects that were recruited into the trial and received at least one course of alemtuzumab therapy will constitute Full Analysis Population.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one course of alemtuzumab therapy within the trial will constitute safety population.

    Primary: Proportion of patients in remission at 6 months

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    End point title
    		 Proportion of patients in remission at 6 months
    End point description
    Proportion of patients in remission at six months
    End point type
    Primary
    End point timeframe
    Remission at 6 months
    End point values
    		 Low dose arm High dose arm Full analysis population
    Number of subjects analysed
    13
    10
    23
    Units: Number
        Remission
    9
    7
    16
        Not in remission
    4
    3
    7
    Statistical analysis title
    		 Logistic regression
    Statistical analysis description
    The odds ratio of achieving complete or partial remission at six months with high dose (low dose reference group) adjusted for age, ANCA subtype and disease duration.
    Comparison groups
    Low dose arm v High dose arm
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.91 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 10.4
    Notes
    [1] - Age: 0.73 PR3: 0.99 ANCA neg: 0.65 Disease duration: 0.82

    Primary: Proportion of patients with Serious adverse events related to IMP

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    End point title
    		 Proportion of patients with Serious adverse events related to IMP [2]
    End point description
    Number of patients that developed serious adverse events (as defined in protocol)
    End point type
    Primary
    End point timeframe
    Over the course of 12 months trial duration
    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: This is primarily a descriptive analysis
    End point values
    		 Low dose arm High dose arm Safety population
    Number of subjects analysed
    13
    10
    23
    Units: Number
        SAE
    4
    3
    7
        No SAE
    9
    7
    16
    Attachments
    		 Serious adverse events
    No statistical analyses for this end point

    Secondary: Proportion of patients with treatment failure

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    End point title
    		 Proportion of patients with treatment failure
    End point description
    Treatment failure was defined as failure to achieve a vasculitis response by 6 months or vasculitis relapse between 6 and 12 months.
    End point type
    Secondary
    End point timeframe
    Over a period of 12 months
    End point values
    		 Low dose arm High dose arm Full analysis population
    Number of subjects analysed
    13
    10
    Units: Number
        Yes
    7
    6
    13
        No
    6
    4
    10
    No statistical analyses for this end point

    Secondary: Proportion of patients with one or more relapses

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    End point title
    		 Proportion of patients with one or more relapses
    End point description
    A vasculitis relapse is defined as the appearance or re-appearance of severe disease (major BVAS/WG item) or appearance or re-appearance of at least two minor BVAS/WG items. Patients who did not achieve remission and are withdrawn (thus technically not possible to satisfy relapse definition) are censored.
    End point type
    Secondary
    End point timeframe
    Over a period of 12 months.
    End point values
    		 Low dose arm High dose arm Full analysis population
    Number of subjects analysed
    12 [3]
    9 [4]
    21 [5]
    Units: Number
        Yes
    9
    5
    14
        No
    3
    4
    7
    Attachments
    		 Untitled (Filename: survival_analysis.docx)
    Notes
    [3] - 1 patient withdrawn due to progressive disease & not satisfying the relapse criteria is removed
    [4] - 1 patient withdrawn due to progressive disease & not satisfying the relapse criteria is removed
    [5] - 2 patients withdrawn due to progressive disease & not satisfying the relapse criteria are removed
    Statistical analysis title
    		 Kaplan Meier
    Statistical analysis description
    Kaplan Meier survival for risk of relapse
    Comparison groups
    Low dose arm v High dose arm
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.67
    Method
    		 Logrank
    Confidence interval
    Notes
    [6] - Kaplan Meier Survival analysis. Log-rank test performed to test the hypothesis that there is no difference in the time to relapse between the two arms.
    Statistical analysis title
    		 Cox regression analysis
    Statistical analysis description
    Cox regression analysis adjusting for age, ANCA subtype and disease duration.
    Comparison groups
    Low dose arm v High dose arm
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.76 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 3.6
    Notes
    [7] - Cox regression analysis
    [8] - Age: 0.81 PR3 ANCA: 0.99 ANCA neg: 0.38 Disease duration: 0.59

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Low Dose
    Reporting group description
    		 -

    Reporting group title
    High Dose
    Reporting group description
    		 -

    Serious adverse events
    		 Low Dose High Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 13 (30.77%)
    3 / 10 (30.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Elevated troponin
    Additional description: Elevated troponin
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine storm
    Additional description: Cytokine storm
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease flare
    Additional description: Disease flare
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    C Diff diarrhoea
    Additional description: C Diff diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CMV colitis
    Additional description: CMV colitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Low Dose High Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    10 / 10 (100.00%)
    Injury, poisoning and procedural complications
    Injury
    Additional description: Injury
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    IRR
    Additional description: IRR
         subjects affected / exposed
    12 / 13 (92.31%)
    10 / 10 (100.00%)
         occurrences all number
    22
    15
    Vascular disorders
    PE
    Additional description: PE
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhytmia
    Additional description: Arrhytmia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Benign intracranial HTN
    Additional description: Benign intracranial HTN
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Headaches
    Additional description: Headaches
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vasovagal
    Additional description: Vasovagal
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Meibomian gland dysfunction
    Additional description: Meibomian gland dysfunction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdo pain
    Additional description: Abdo pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Periodonitis
    Additional description: Periodonitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    IgA dermatosis
    Additional description: IgA dermatosis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Intertrigo
    Additional description: Intertrigo
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Hallucinations: drug induced
    Additional description: Hallucinations: drug induced
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroid
    Additional description: Hypothyroid
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    CMV
    Additional description: CMV
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    CMV viraemia
    Additional description: CMV viraemia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    LRTI
    Additional description: LRTI
         subjects affected / exposed
    5 / 13 (38.46%)
    6 / 10 (60.00%)
         occurrences all number
    9
    6
    Ocular infection
    Additional description: Ocular infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    PR bleed
    Additional description: PR bleed
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Root canal infection
    Additional description: Root canal infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Thrush
    Additional description: Thrush
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    URTI
    Additional description: URTI
         subjects affected / exposed
    4 / 13 (30.77%)
    5 / 10 (50.00%)
         occurrences all number
    4
    5
    Uterine infection
    Additional description: Uterine infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    UTI
    Additional description: UTI
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 10 (10.00%)
         occurrences all number
    3
    2
    Vaginal candidiasis
    Additional description: Vaginal candidiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 May 2015
    Changes to PIS with updated SmPC (PML)
    30 Sep 2016
    Changes to PIS with new safety information as per updated SmPC
    30 Oct 2016
    Updated patient information sheet to bring it in line with the updated SmPC safety information
    06 Jul 2017
    Amendment submitted to update the trial protocol to align with MHRA process for reference safety information (RSI) management, with added reference to the latest approved RSI for alemtuzumab

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Aug 2013
    In August 2012, Genzyme temporarily withdrew alemtuzumab. This was a commercial decision made prior to them submitting alemtuzumab for approval as a treatment of relapsing-remitting multiple sclerosis. The trial was temporarily interrupted between Aug 2012 and September 2013
    01 Sep 2013

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The recruitment was rather long due to a small pool of patients that are eligible to enter the trial.
    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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