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    Clinical Trial Results:
    A Multicenter, Open-label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis

    Summary
    EudraCT number
    2014-000917-30
    Trial protocol
    DE   IT   DK   BE  
    Global end of trial date
    04 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    14 May 2016
    First version publication date
    14 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    101MS207
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02142192
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    225 Binney Street, Cambridge, Massachusetts , United States, 02142
    Public contact
    Biogen Study Medical Director, Biogen , clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen , clinicaltrials@biogen.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
    04 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the immunogenicity of natalizumab 300 mg subcutaneous (SC) administered to subjects with relapsing multiple sclerosis (RMS). The secondary objectives are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.
    Protection of trial subjects
    Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Through the informed consent process each subject was made aware of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jan 2015
    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: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subject eligibility for the study was determined within approximately 6 weeks prior to study entry. The screening period was extended if there were unforeseen delays in receiving laboratory results necessary for assessing eligibility.

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

    Arms
    Arm title
    Natalizumab
    Arm description
    Natalizumab 300 mg SC every 4 weeks for up to 44 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    natalizumab
    Investigational medicinal product code
    Other name
    Tysabri
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to be treated with open-label natalizumab (300 mg SC) at Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

    Number of subjects in period 1
    Natalizumab
    Started
    2
    Completed
    0
    Not completed
    2
         Sponsor decision to terminate trial
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Natalizumab
    Reporting group description
    Natalizumab 300 mg SC every 4 weeks for up to 44 weeks

    Reporting group values
    Natalizumab Total
    Number of subjects
    2 2
    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)
    2 2
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    1 1
        Male
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Natalizumab
    Reporting group description
    Natalizumab 300 mg SC every 4 weeks for up to 44 weeks

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population was defined as all subjects who received at least 1 dose of study treatment and had at least 1 post-baseline assessment of the parameter being analyzed.

    Primary: Number of Subjects With Persistent Anti-natalizumab Antibodies Over 48 Weeks

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    End point title
    Number of Subjects With Persistent Anti-natalizumab Antibodies Over 48 Weeks [1]
    End point description
    Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit. Due to early termination, assessments were completed at screening, post-baseline Week 12, and at Safety Follow-up (12 weeks after last dose administered).
    End point type
    Primary
    End point timeframe
    Screening, Post-Baseline Week 12, Safety Follow-up (12 weeks after last dose administered [up to 172 days])
    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: No statistical analyses of the data were performed, since only 2 subjects were enrolled prior to study termination. Data were listed only.
    End point values
    Safety population
    Number of subjects analysed
    2
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Post-injection Adverse Events (AEs)

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    End point title
    Number of Subjects with Post-injection Adverse Events (AEs)
    End point description
    The number of subjects with post-injection AEs including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.
    End point type
    Secondary
    End point timeframe
    Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
    End point values
    Safety population
    Number of subjects analysed
    2
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Relapse or With New or Enlarging T2 Lesions

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    End point title
    Number of Subjects With Clinical Relapse or With New or Enlarging T2 Lesions
    End point description
    The number of subjects with clinical relapse, or with new or enlarging T2 lesion(s), as determined by a central MRI reading center, over 48 weeks. Clinical relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurologic findings upon examination by the Neurologist. The subject must have had objective signs on the neurologist’s examination that confirm the event.
    End point type
    Secondary
    End point timeframe
    Up to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
    End point values
    Safety population
    Number of subjects analysed
    2
    Units: Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Gadolinium (Gd)-enhancing Lesions

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    End point title
    Number of Subjects With Gadolinium (Gd)-enhancing Lesions
    End point description
    Brain MRI scans were planned to occur during screening and then again at the Week 48 Visit and were to include T2 as well as T1 sequences with and without gadolinium (Gd). The data from all of the scheduled MRI scans were evaluated at a central MRI reading center to determine the level of disease activity. Due to early termination of the study, scans were performed at screening only.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    Natalizumab
    Number of subjects analysed
    2
    Units: Subjects
        number (not applicable)
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With AEs and Serious AEs (SAEs)

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    End point title
    Number of Subjects With AEs and Serious AEs (SAEs)
    End point description
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose (i) results in death, (ii) places the subject at immediate risk of death, (iii) requires inpatient hospitalization or prolongation of existing hospitalization, (iv) results in persistent or significant disability/incapacity or (v) results in a congenital anomaly/birth defect.
    End point type
    Secondary
    End point timeframe
    AEs: Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days]); SAEs: Informed Consent to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
    End point values
    Safety population
    Number of subjects analysed
    2
    Units: Subjects
        number (not applicable)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days]); SAEs: Informed Consent to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    All subjects who received at least 1 dose of study treatment and had at least 1 post-baseline assessment.

    Serious adverse events
    Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated early by Biogen. This decision was independent of any safety, efficacy, or regulatory concerns related to natalizumab.
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