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    Clinical Trial Results:
    A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab

    Summary
    EudraCT number
    2016-000464-42
    Trial protocol
    DE  
    Global end of trial date
    28 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Jun 2020
    First version publication date
    11 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALEMLL08091
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1185-1377
    Other trial identifiers
    Sponsor abbreviated name: LemCourse
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, MA, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    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 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of effectiveness of an additional alemtuzumab course in subjects with relapsing remitting multiple sclerosis (RRMS) with disease activity after 2 courses with respect to the annualised relapse rate (ARR).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial in which the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at multiple sites in Germany between 04-October-2016 to 28-May-2019.

    Pre-assignment
    Screening details
    A total of 56 subjects were included in the study.

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

    Arms
    Arm title
    Alemtuzumab
    Arm description
    Subjects who had previously (before enrollment in this study) received 2 courses of alemtuzumab, received intravenous (IV) infusion of alemtuzumab in this study at a dose of 12 milligram per day (mg/day) for 3 consecutive days, at least 12 months after prior treatment course.
    Arm type
    Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    Lemtrada
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion of alemtuzumab at a dose of 12 mg/day for 3 consecutive days (total dose-36 mg) at least 12 months after prior treatment course in a supervised medical setting.

    Number of subjects in period 1
    Alemtuzumab
    Started
    56
    Completed
    54
    Not completed
    2
         Subject did not meet inclusion/exclusion criteria
    1
         Adverse Event (AE)
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alemtuzumab
    Reporting group description
    Subjects who had previously (before enrollment in this study) received 2 courses of alemtuzumab, received intravenous (IV) infusion of alemtuzumab in this study at a dose of 12 milligram per day (mg/day) for 3 consecutive days, at least 12 months after prior treatment course.

    Reporting group values
    Alemtuzumab Total
    Number of subjects
    56 56
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.8 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    44 44
        Male
    12 12

    End points

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    End points reporting groups
    Reporting group title
    Alemtuzumab
    Reporting group description
    Subjects who had previously (before enrollment in this study) received 2 courses of alemtuzumab, received intravenous (IV) infusion of alemtuzumab in this study at a dose of 12 milligram per day (mg/day) for 3 consecutive days, at least 12 months after prior treatment course.

    Subject analysis set title
    Alemtuzumab (1-year period prior to 3rd course of treatment)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Subjects who, after receiving 2nd course of treatment with alemtuzumab, were in a year-long period of observation before administration of 3rd treatment course with alemtuzumab.

    Subject analysis set title
    Alemtuzumab (1-year period after 3rd course of treatment)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Subjects who were observed for up to one year after administration of 1st infusion of the 3rd treatment course with alemtuzumab.

    Primary: Annualized Number of Relapses During the 1-year Period of Observation Before and After Third Treatment Course With Alemtuzumab

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    End point title
    Annualized Number of Relapses During the 1-year Period of Observation Before and After Third Treatment Course With Alemtuzumab
    End point description
    Relapse was defined as new neurological or worsening of previous neurological symptoms with an objective change on neurological examination. These symptoms were attributable to multiple sclerosis, lasting at least 48 hours, be present at normal body temperature (i.e., no infection, excessive exercise, or excessively high ambient temperature), and be preceded by at least 30 days of clinical stability. Analysis was performed on modified intent-to-treat (mITT) population which included all subjects who had received at least one infusion of the 3rd treatment course with alemtuzumab with non-missing information regarding duration of follow-up after 1st infusion of the 3rd treatment course with alemtuzumab and number of relapses during this follow-up.
    End point type
    Primary
    End point timeframe
    Up to 12 months before and after 3rd treatment course of alemtuzumab
    End point values
    Alemtuzumab (1-year period prior to 3rd course of treatment) Alemtuzumab (1-year period after 3rd course of treatment)
    Number of subjects analysed
    56
    56
    Units: Normalised number of relapses per year
        arithmetic mean (standard deviation)
    1.34 ± 0.824
    0.58 ± 0.924
    Statistical analysis title
    Rate ratio
    Statistical analysis description
    System sums group Ns for "N in analysis", actual N=56. Repeated measures negative binomial regression model compared relapses in year after 3rd treatment course with relapses in year prior with independent factor gender, covariate age and logarithm of duration of corresponding follow-up time as offset variable. Estimates were provided for ARR in the 2 periods and rate ratio (after/before) of ARRs. Null hypothesis H0:RR ≥1 was tested versus H1:RR <1 at 0.025 level.
    Comparison groups
    Alemtuzumab (1-year period prior to 3rd course of treatment) v Alemtuzumab (1-year period after 3rd course of treatment)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.29
         upper limit
    0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.186

    Primary: Number of Subjects With Sustained Accumulation of Disability (SAD)

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    End point title
    Number of Subjects With Sustained Accumulation of Disability (SAD) [1]
    End point description
    SAD was defined as an increase of at least 1 point on the expanded disability status scale (EDSS) from baseline EDSS score ≥1.0 (1.5 point increase for subjects with baseline EDSS of 0). An EDSS was an ordinal clinical rating scale which ranges from 0 (normal neurologic examination) to 10 (death due to multiple sclerosis) in half-point increments, where lower score indicated less severity. Analysis was performed on mITT population. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    12 months post 3rd treatment course of alemtuzumab
    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: The endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    Alemtuzumab
    Number of subjects analysed
    55
    Units: subjects
    number (not applicable)
        Yes
    7
        No
    48
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Without Relapse at Month 12

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    End point title
    Percentage of Subjects Without Relapse at Month 12
    End point description
    Relapse was defined as new neurological or worsening of previous neurological symptoms with an objective change on neurological examination. These symptoms were attributable to multiple sclerosis, lasting at least 48 hours, be present at normal body temperature (i.e., no infection, excessive exercise, or excessively high ambient temperature), and be preceded by at least 30 days of clinical stability. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: percentage of subjects
        number (not applicable)
    66.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Expanded Disability Status Scale Scores at Months 6 and 12

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    End point title
    Change From Baseline in Expanded Disability Status Scale Scores at Months 6 and 12
    End point description
    The EDSS was used as the standard for assessing disability in subjects with multiple sclerosis. It was an ordinal clinical rating scale which ranges from 0 (normal neurologic examination) to 10 (death due to multiple sclerosis) in half-point increments where lower score indicated less severity. EDSS steps 1.0 to 4.5 referred to subject with multiple sclerosis who were fully ambulatory, while EDSS steps 5.0 to 9.5 were defined by the impairment to ambulation. Analysis was performed on mITT population. Here, “number of subjects analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    55
    Units: score on a scale
    arithmetic mean (standard deviation)
        Month 6
    -0.2 ± 0.73
        Month 12
    -0.1 ± 0.86
    No statistical analyses for this end point

    Secondary: Brain Magnetic Resonance Imaging (MRI) Assessment: Percentage of Subjects With Active Lesions

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    End point title
    Brain Magnetic Resonance Imaging (MRI) Assessment: Percentage of Subjects With Active Lesions
    End point description
    The MRI was used to evaluate the efficacy of drug modifying therapies (DMTs) by measuring the number of unique active lesion (UALs): Gadolinium-enhancing (Gd)(+)-lesions seen in T1-weighted images plus unenhanced new and enlarging T2-hyperintense lesions, identified on relatively infrequent sequential imaging. Change of number of Gd(+)-lesions and number of new and enlarging lesions found on T2-weighted images were evaluated at Month 12 as compared to Baseline. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: percentage of subjects
    number (not applicable)
        New Gd lesions: Baseline
    35.7
        New Gd lesions: Month 12
    12.5
        New T2 lesions: Baseline
    37.5
        New T2 lesions: Month 12
    14.3
        New lesions (Gd or T2): Baseline
    53.6
        New lesions (Gd or T2): Month 12
    19.6
        Any enlarging T2 lesion: Month 12
    8.9
    No statistical analyses for this end point

    Secondary: Brain Magnetic Resonance Imaging Assessment: Change from Baseline in Number of Active Gadolinium-enhancing and T2 Lesions at Month 12

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    End point title
    Brain Magnetic Resonance Imaging Assessment: Change from Baseline in Number of Active Gadolinium-enhancing and T2 Lesions at Month 12
    End point description
    The MRI was used to evaluate the efficacy of DMTs by measuring the number of UALs: Gd(+)-lesions seen in T1-weighted images plus unenhanced new and enlarging T2-hyperintense lesions, identified on relatively infrequent sequential imaging. Change of number of Gd(+)-lesions and number of new and enlarging lesions found on T2-weighted images were evaluated at Month 12 as compared to Baseline. Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: lesions
    arithmetic mean (standard deviation)
        New Gd lesions: (n=53)
    -0.77 ± 3.017
        New T2 lesions: (n=54)
    -2.37 ± 8.295
        New lesions (Gd+T2): (n=53)
    -3.19 ± 9.058
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Scores at Months 6 and 12

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    End point title
    Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Scores at Months 6 and 12
    End point description
    SDMT was developed to identify subjects with neurological impairment and had demonstrated remarkable sensitivity in detecting changes in cognitive functioning over time and in response to treatment. The SDMT involves a simple substitution task. Using a reference key, the subject had 90 seconds to identify nine different symbols corresponding to the numbers 1 through 9, paired specific numbers with given geometric figures, and practiced writing the correct number under the corresponding symbol. The total number of symbols to recognise was 120 corresponding to a maximal score of 120, where the lower score indicated more cognitive impairment. Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Month 6 (n=54)
    1 ± 14.6
        Month 12 (n=53)
    3 ± 17.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Questionnaire at Months 6 and 12

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    End point title
    Change From Baseline in Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Questionnaire at Months 6 and 12
    End point description
    The PRIMUS was a disease specific subject-reported outcome questionnaire that measured the quality of life (QoL) of subjects suffering from multiple sclerosis. The PRIMUS scores were evaluated by assessment of QoL, activity limitations, and symptoms. The questionnaire contained 22 questions on QoL, 15 on activity limitations and 8 on symptoms. A rank was associated to each answer: symptom questions: Yes=1; No=0, activity questions: could without difficulty=0; could with difficulty=1; could not=2, and QoL questions: Not correct=0; Correct=1. The ranks were then summed by specific domains (QoL, activity limitations, and symptoms) and overall. These sums were normalised on the maximum possible scores and presented as percentage (%), where higher score on any of these scales indicated lower quality of life due to the disease. Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Symptom Score: Month 6 (n=55)
    -2.8 ± 16.62
        Symptom Score: Month 12 (n=53)
    -1.5 ± 17.84
        Activity Score: Month 6 (n=55)
    -1.0 ± 12.89
        Activity Score: Month 12 (n=53)
    0.3 ± 13.21
        Quality-of-Life Score: Month 6 (n=55)
    -5.0 ± 20.00
        Quality-of-Life Score: Month 12 (n=53)
    -3.3 ± 17.95
        Overall Score: Month 6 (n=55)
    -2.7 ± 12.22
        Overall Score: Month 12 (n=53)
    -1.3 ± 12.26
    No statistical analyses for this end point

    Secondary: Changes From Baseline in Euro Quality of life (EQ-5D-3L) at Months 6 and 12- Index Scores

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    End point title
    Changes From Baseline in Euro Quality of life (EQ-5D-3L) at Months 6 and 12- Index Scores
    End point description
    An EQ-5D was a standardised measure to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D 3L consisted of 2 pages: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each had 3 levels of severity (no problems, some problems, and extreme problems). The 5-dimensional 3-level systems were converted into a single index utility score between 0 to 1, where higher score indicates a better health state. Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: score on a scale
    arithmetic mean (standard deviation)
        At Month 6 (n=54)
    0.040 ± 0.1514
        At Month 12 (n=52)
    0.040 ± 0.1568
    No statistical analyses for this end point

    Secondary: Changes From Baseline in Euro Quality of life at Months 6 and 12- Visual Analogue Scale Scores

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    End point title
    Changes From Baseline in Euro Quality of life at Months 6 and 12- Visual Analogue Scale Scores
    End point description
    EQ-5D was a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-3L-VAS recorded the subject’s self-rated health on a vertical VAS that allowed the subjects to indicate their health state that could range from 0 (worst imaginable) to 100 (best imaginable). Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: score on a scale
    arithmetic mean (standard deviation)
        At Month 6 (n=55)
    1 ± 15.8
        At Month 12 (n=53)
    3 ± 17.8
    No statistical analyses for this end point

    Secondary: Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) Scores at Months 6 and 12

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    End point title
    Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) Scores at Months 6 and 12
    End point description
    WPAI-GH consisted of 6 questions (Q): 1=currently employed; 2=hours missed due to health problems; 3=hours missed because of other reasons; 4=hours actually worked; 5=degree health affected productivity while working (using 0 to 10 VAS); 6=degree health affected productivity in regular unpaid activities (VAS). 4 outcomes were generated, expressed in % by multiplying scores by 100: 1) Work time % missed due to health=Q2/(Q2 + Q4) for currently employed; 2) Impairment % while working due to health=Q5/10 for currently employed and actually worked in past 7 days; 3) Overall work impairment % due to health Q2/(Q2+Q4)+([1-Q2/(Q2+Q4])*[Q5/10]) for currently employed; 4) Activity impairment % due to health Q6/10 for all respondents. Subjects who missed work/did not work in past 7 days, overall work impairment % due to health was equal to work time % missed due to health. Analysis was performed on mITT population. Here, “n” signifies number of subjects analysed for each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 6 and 12
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Score 1: Month 6 (n=15)
    -5.4 ± 27.13
        Score 1: Month 12 (n=15)
    -9.6 ± 45.92
        Score 2: Month 6 (n=21)
    -3.3 ± 20.08
        Score 2: Month 12 (n=21)
    -7.1 ± 22.83
        Score 3: Month 6 (n=14)
    -0.6 ± 23.46
        Score 3: Month 12 (n=14)
    -12.3 ± 31.13
        Score 4: Month 6 (n=55)
    -5.6 ± 22.09
        Score 4: Month 12 (n=51)
    -5.1 ± 27.88
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)/Serious Adverse Events (SAEs)/Adverse Events of Special Interest (AESIs)

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    End point title
    Number of Subjects With Treatment-emergent Adverse Events (TEAEs)/Serious Adverse Events (SAEs)/Adverse Events of Special Interest (AESIs)
    End point description
    An AE was any untoward medical occurrence in subject or clinical investigation subject administered a pharmaceutical product and which did not necessarily had a causal relationship with this treatment. A TEAE was AE that occurred from the start of the 1st infusion of 3rd treatment course up to 1 year after 1st infusion of 3rd treatment course. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalisation/prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or medically important event. An AESI was an AE (serious/non-serious) of scientific and medical concern specific to Sponsor’s product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. Analysis was performed on safety population that included all subjects who had received at least 1 infusion of 3rd treatment course.
    End point type
    Secondary
    End point timeframe
    From Baseline up to 12 months
    End point values
    Alemtuzumab
    Number of subjects analysed
    56
    Units: subjects
        TEAEs
    52
        SAEs
    17
        AESIs
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are the treatment-emergent adverse events, that is, AEs that developed/worsened during the ‘treatment emergent period’ (the time from the first dose of study drug up to the 12 months post third course of treatment). Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Alemtuzumab
    Reporting group description
    Subjects who had previously (before enrollment in this study) received 2 courses of alemtuzumab, received IV infusion of alemtuzumab in this study at a dose of 12 mg/day for 3 consecutive days, at least 12 months after prior treatment course.

    Serious adverse events
    Alemtuzumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 56 (30.36%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Multiple Sclerosis Relapse Prophylaxis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Nuclear Magnetic Resonance Imaging Brain Abnormal
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Multiple Sclerosis Relapse
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences causally related to treatment / all
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Endocrine Ophthalmopathy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thyrotoxic Crisis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Chest Wall Abscess
         subjects affected / exposed
    1 / 56 (1.79%)
         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
    Alemtuzumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 56 (73.21%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 56 (25.00%)
         occurrences all number
    17
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Rash
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Back Pain
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Muscle Spasms
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 56 (21.43%)
         occurrences all number
    13
    Sinusitis
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Urinary Tract Infection
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    5

    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.
    None reported
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