Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41190   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Prospective, Non-interventional, Multicenter, Open-label Safety and Efficacy Study of Intravenous Natalizumab Administered to Patients With Relapsing Forms of Multiple Sclerosis who Participated in STRATA

    Summary
    EudraCT number
    2014-003669-97
    Trial protocol
    BE  
    Global end of trial date
    12 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    BEL-TYS-14-10675
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    250 Binney Street, Cambridge, 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
    12 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective for this study was long-term safety (incidence and pattern of serious adverse events) in subjects receiving natalizumab.
    Protection of trial subjects
    Written informed consent was obtained from each subject prior to evaluations 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
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Dec 2014
    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: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Subjects were recruited from 4 sites in Belgium.

    Pre-assignment
    Screening details
    A total of 7 subjects with relapsing forms of multiple sclerosis were enrolled in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Natalizumab 300 milligram (mg)
    Arm description
    Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Natalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks

    Number of subjects in period 1
    Natalizumab 300 milligram (mg)
    Started
    7
    Completed
    3
    Not completed
    4
         Subject moved to another center
    1
         Unknown
    1
         Consent withdrawn by subject
    1
         Treatment Stopped
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks.

    Reporting group values
    Overall Period Total
    Number of subjects
    7
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        median (full range (min-max))
    59 (18 to 61) -
    Gender Categorical
    Units: Subjects
        Female
    6 6
        Male
    1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Natalizumab 300 milligram (mg)
    Reporting group description
    Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks.

    Primary: Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Close Top of page
    End point title
    Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a subject 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 results in death, places the subject at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. Safety analysis set included all subjects enrolled in the study.
    End point type
    Primary
    End point timeframe
    up to 96 weeks
    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 analysis was planned to be reported for this endpoint.
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: subjects
        AEs
    5
        SAEs
    1
    No statistical analyses for this end point

    Secondary: Expanded Disability Status Scale (EDSS) Score to Measure Disability Progression at Week 0, 24, 48, 72 and 96

    Close Top of page
    End point title
    Expanded Disability Status Scale (EDSS) Score to Measure Disability Progression at Week 0, 24, 48, 72 and 96
    End point description
    EDSS is used to measure disability progression. EDSS score ranges from 0.0 (normal neurological exam) to 10.0 (death due to multiple sclerosis {MS}). Disability progression is defined as 1.5-point increase from baseline in subjects with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in subjects with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in subjects with baseline EDSS score >5.0. Higher scores indicates worsening of disability progression. Full analysis set (FAS) included all subjects enrolled in the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48, 72 and 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: score on a scale
    median (full range (min-max))
        Week 0
    2.0 (2.0 to 2.5)
        Week 24
    2.5 (2.0 to 2.5)
        Week 48
    2.5 (2.0 to 2.5)
        Week 72
    2.5 (2.0 to 2.5)
        Week 96
    2.25 (2.0 to 2.5)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinical Relapses

    Close Top of page
    End point title
    Number of Subjects with Clinical Relapses
    End point description
    Multiple Sclerosis (MS) disease activity was assessed by the occurrence of clinical relapses over the study period. FAS included all subjects enrolled in the study.
    End point type
    Secondary
    End point timeframe
    up to week 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: subjects
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Positive Anti-JC Virus (JCV) Antibodies

    Close Top of page
    End point title
    Percentage of Subjects with Positive Anti-JC Virus (JCV) Antibodies
    End point description
    FAS included all subjects enrolled in the study. Here, '99999' signifies data was not collected at Week 96 for subjects with positive anti-JC virus.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48, 72 and 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: percentage of subjects
        Week 0
    71
        Week 24
    80
        Week 48
    75
        Week 72
    100
        Week 96
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Frequent Magnetic Resonance Imaging (MRI) Monitoring at Week 24, 48, 72 and 96

    Close Top of page
    End point title
    Percentage of Subjects With Frequent Magnetic Resonance Imaging (MRI) Monitoring at Week 24, 48, 72 and 96
    End point description
    MRI monitoring in MS subjects performed as per Belgian Study Group of MS (BSGMS) guidelines. FAS included all subjects enrolled in the study.
    End point type
    Secondary
    End point timeframe
    Week 24, 48, 72 and 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: percentage of subjects
    number (not applicable)
        Week 24
    29
        Week 48
    0
        Week 72
    50
        Week 96
    50
    No statistical analyses for this end point

    Secondary: EuroQol-5D (EQ-5D) Score to Assess Quality of life (QoL) at Week 0, 24, 48, 72 and 96

    Close Top of page
    End point title
    EuroQol-5D (EQ-5D) Score to Assess Quality of life (QoL) at Week 0, 24, 48, 72 and 96
    End point description
    The health-related quality of life (HRQoL) was measured using the global evaluation scale of the EuroQol-5 Dimensions (EQ-5D) questionnaire every 6 months. Subjects were asked to evaluate their health status on a scale from 0 (worst possible health status) to 10 (best possible health status). Highest scores indicates healthy quality of life. A average score for all the subjects were reported. FAS included all subjects enrolled in the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48, 72 and 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    7
    Units: score on a scale
    median (full range (min-max))
        Week 0
    7.00 (7.00 to 7.50)
        Week 24
    7.00 (7.00 to 7.50)
        Week 48
    7.50 (7.00 to 7.50)
        Week 72
    7.50 (7.00 to 7.50)
        Week 96
    7.00 (7.00 to 7.50)
    No statistical analyses for this end point

    Secondary: Cognitive Evaluation by Symbol Digit Modalities Test (SDMT) at Week 0, 24, 48, 72 and 96

    Close Top of page
    End point title
    Cognitive Evaluation by Symbol Digit Modalities Test (SDMT) at Week 0, 24, 48, 72 and 96
    End point description
    Data for this endpoint was not collected.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48, 72 and 96
    End point values
    Natalizumab 300 milligram (mg)
    Number of subjects analysed
    0 [2]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [2] - Data was not collected.
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 96 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    PI observed events
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Natalizumab 300 mg
    Reporting group description
    Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks.

    Serious adverse events
    Natalizumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Fracture (right malleolar)
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Natalizumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    General disorders and administration site conditions
    Fracture (4th right finger)
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Common cold
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Diarrhea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Abdominal cramps
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Allergic reaction to spiruline
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Urinary infection
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Throat infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastric reflux
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

    Close Top of page

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA