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    Clinical Trial Results:
    A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201

    Summary
    EudraCT number
    2015-003618-26
    Trial protocol
    GB   HU   CZ   ES   DE   BE   SE   DK  
    Global end of trial date
    23 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Feb 2018
    First version publication date
    08 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    215ON203
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02657915
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    250 Binney Street, Cambridge, United States, 02142
    Public contact
    Study Director, Biogen, +1 866-633-4636, clinicaltrials@biogen.com
    Scientific contact
    Study Director, Biogen, +1 866-633-4636, 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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in the parent Study 215ON201 (hereafter referred to as RENEW) at 2 years (+ up to 12 months) after the last study visit.
    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 Form (ICF) and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Subjects were provided with a copy of the signed and dated ICF.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Mar 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
    Belgium: 2
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    52
    EEA total number of subjects
    44
    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)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The number of subjects eligible for this study was determined by the number of subjects who participated in RENEW. A total of 82 subjects were enrolled in RENEW and received at least 1 dose of study treatment. A total of 52 subjects participated in this study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst
    Blinding implementation details
    This was a follow-up study with no investigational product; however, the allocation method in RENEW was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or subjects until the end of this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    This was a follow-up study with no investigational product administered. Subjects in the placebo arm had received at least 1 dose of placebo in RENEW.
    Arm type
    Placebo

    Investigational medicinal product name
    Sterile normal saline (0.9% sodium chloride for IV administration)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm

    Arm title
    BIIB033 100mg/Kg
    Arm description
    This was a follow-up study with no investigational product administered. Subjects in the BIIB033 arm had received at least 1 dose of 100 mg/kg BIIB033 in RENEW.
    Arm type
    Experimental

    Investigational medicinal product name
    BIIB033 100 mg/Kg
    Investigational medicinal product code
    Other name
    Opicinumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Number of subjects in period 1
    Placebo BIIB033 100mg/Kg
    Started
    24
    28
    Completed
    24
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    This was a follow-up study with no investigational product administered. Subjects in the placebo arm had received at least 1 dose of placebo in RENEW.

    Reporting group title
    BIIB033 100mg/Kg
    Reporting group description
    This was a follow-up study with no investigational product administered. Subjects in the BIIB033 arm had received at least 1 dose of 100 mg/kg BIIB033 in RENEW.

    Reporting group values
    Placebo BIIB033 100mg/Kg Total
    Number of subjects
    24 28 52
    Age Categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    24 28 52
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.6 ± 7.96 34.6 ± 6.57 -
    Gender Categorical
    Units: Subjects
        Female
    19 19 38
        Male
    5 9 14

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    This was a follow-up study with no investigational product administered. Subjects in the placebo arm had received at least 1 dose of placebo in RENEW.

    Reporting group title
    BIIB033 100mg/Kg
    Reporting group description
    This was a follow-up study with no investigational product administered. Subjects in the BIIB033 arm had received at least 1 dose of 100 mg/kg BIIB033 in RENEW.

    Primary: FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in Study 215ON201 (RENEW)

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    End point title
    FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in Study 215ON201 (RENEW)
    End point description
    A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The PP population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm at each time point is indicated by "n".
    End point type
    Primary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: milliseconds (msec)
    arithmetic mean (standard deviation)
        Baseline (n= 22, 24)
    100.68 ± 4.854
    102.29 ± 5.507
        Day 1 (n=21, 23)
    119.52 ± 13.395
    114.20 ± 14.235
    Statistical analysis title
    Placebo Vs. BIIB033
    Comparison groups
    BIIB033 100mg/Kg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.165
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.56
         upper limit
    2.57

    Secondary: Number of Subjects that Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW

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    End point title
    Number of Subjects that Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW
    End point description
    Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: Number of Subjects
    12
    12
    No statistical analyses for this end point

    Secondary: Time to Diagnosis of CDMS

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    End point title
    Time to Diagnosis of CDMS
    End point description
    Measured in Days using the Median (50th percentile) for each arm. NOTE: The value of 9999.99 for the max of the inter-quartile range = NA. Data is not reported for this value as it was not observed during this study.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: Days
        median (inter-quartile range (Q1-Q3))
    386.0 (212.0 to 1065.0)
    909.5 (281.0 to 9999.99)
    No statistical analyses for this end point

    Secondary: Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)

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    End point title
    Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
    End point description
    The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm is indicated by "n".
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: EDSS Total Score
    arithmetic mean (standard deviation)
        n=23, 21
    1.22 ± 0.837
    1.26 ± 1.136
    No statistical analyses for this end point

    Secondary: Severity of CNS Demyelinating Disease as Assessed Using the Symbol-Digit Modalities Test (SDMT)

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    End point title
    Severity of CNS Demyelinating Disease as Assessed Using the Symbol-Digit Modalities Test (SDMT)
    End point description
    SDMT is a screening test for cognitive impairment. Subjects are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm is indicated by "n".
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: SDMT Total Score
    arithmetic mean (standard deviation)
        n= 22, 20
    56.7 ± 9.91
    58.7 ± 9.01
    No statistical analyses for this end point

    Secondary: Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment

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    End point title
    Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
    End point description
    The MSFC is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The three components of the MSFC are: (1) measure leg function/ambulation, (2) measure arm/hand function, and (3) measure cognitive function. MSFC is reported as a Z-score where higher scores represent better neurological function. originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm is indicated by "n".
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: Z-score
    arithmetic mean (standard deviation)
        n= 20, 21
    -0.82 ± 2.883
    -0.06 ± 0.804
    No statistical analyses for this end point

    Secondary: Change in Number of Gadolinium (Gd)-Enhanced Lesions from Baseline in RENEW to Day 1

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    End point title
    Change in Number of Gadolinium (Gd)-Enhanced Lesions from Baseline in RENEW to Day 1
    End point description
    Number of consensus GD-enhanced lesions as compared to baseline. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm at each time point is indicated by "n".
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: Number of Lesions
    arithmetic mean (standard deviation)
        Baseline n=22, 24
    0.2 ± 0.69
    0.1 ± 0.41
        Change from Baseline to Day 1 n= 21, 19
    0.2 ± 1.54
    -0.1 ± 0.46
    No statistical analyses for this end point

    Secondary: Change in Volume of T2 Lesions from Baseline in RENEW to Day 1

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    End point title
    Change in Volume of T2 Lesions from Baseline in RENEW to Day 1
    End point description
    Volume of T2 lesions as compared to baseline. Primary analysis for this endpoint was performed in the Per Protocol (PP) population and data from this population are presented below. The Per Protocol (PP) population was defined as subjects from the intent-to-treat (ITT) population who completed the study, did not miss more than one dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS) modifying therapies in RENEW. The number of subjects analysed in each arm at each time point is indicated by "n".
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo BIIB033 100mg/Kg
    Number of subjects analysed
    23
    24
    Units: Millilitres (mL)
    arithmetic mean (standard deviation)
        Baseline n= 22, 24
    0.9710 ± 0.93551
    0.7341 ± 1.29222
        Change from Baseline to Day 1 n= 21, 19
    0.5090 ± 1.38861
    0.6244 ± 0.74850
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1
    Adverse event reporting additional description
    The safety population was defined as all subjects who received at least 1 dose of study treatment in RENEW and completed at least 1 of the 1-day assessments in this study. There were no Adverse Events or Serious Adverse Events observed or reported in this study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    BIIB033 100mg/Kg
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    BIIB033 100mg/Kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BIIB033 100mg/Kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 24 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious adverse events recorded as none were observed during this study.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2015
    The primary reason for this amendment is to add adverse event (AE) reporting from the signing of the ICF throughout the study and to specify that AEs and serious AEs (SAEs) will be evaluated as possibly related to prior treatment with investigational drug (administered in Study 215ON201) in addition to those possibly related to study procedure(s).
    08 Jun 2016
    The primary reason for this amendment is to extend the length of time that subjects are eligible for study participation following the completion of Study 215ON201 from 2 years (+ 4 months) to 2 years (+ up to 12 months) after the last study visit.

    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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