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   41189   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:
    Multicentre interventional Phase IV study for the assessment of the effects on patient’s satisfaction of Plegridy® (pre-filled pen) in subjects with relapsing-remitting multiple sclerosis unsatisfied with other injectable subcutaneous Interferons

    Summary
    EudraCT number
    2015-002201-11
    Trial protocol
    IT  
    Global end of trial date
    21 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Nov 2019
    First version publication date
    02 Nov 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    ITA-PEG-14-10779
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02587065
    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
    21 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to investigate whether Peg-IFN beta-1a improves the satisfaction of relapsing-remitting multiple sclerosis (RRMS) subjects unsatisfied with injectable subcutaneous interferons.
    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
    03 Feb 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
    Italy: 193
    Worldwide total number of subjects
    193
    EEA total number of subjects
    193
    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)
    193
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Subjects were recruited from 32 sites in Italy.

    Pre-assignment
    Screening details
    A total of 193 subjects with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study.

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

    Arms
    Arm title
    Peg-interferon Beta-1a 125 μg
    Arm description
    Subjects received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Subjects received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Peg-interferon beta-1a
    Investigational medicinal product code
    Other name
    Peg INF beta-1a, Plegridy®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single 125 μg Peg-interferon beta-1a subcutaneously every two weeks.

    Number of subjects in period 1
    Peg-interferon Beta-1a 125 μg
    Started
    193
    Completed
    166
    Not completed
    27
         Non-adherence to the protocol
    3
         Discontinuation of study medication
    2
         tWithdrawal of Informed Consent (IC)
    5
         Reasons not Specified
    3
         Adverse Event
    14

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Peg-interferon Beta-1a 125 μg
    Reporting group description
    Subjects received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Subjects received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.

    Reporting group values
    Peg-interferon Beta-1a 125 μg Total
    Number of subjects
    193 193
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    42.0 ± 10.6 -
    Sex: Female, Male
    Units: Subjects
        Female
    135 135
        Male
    58 58
    Race/Ethnicity
    Units: Subjects
        Caucasian
    192 192
        Other
    1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Peg-interferon Beta-1a 125 μg
    Reporting group description
    Subjects received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Subjects received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.

    Primary: Change from Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12

    Close Top of page
    End point title
    Change from Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 [1]
    End point description
    TSQM: 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, five items related to side effects of medication were not included. The scores were computed by adding items for each domain. Lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by subjects, by means of a subject i-PAD at each study visit. Full analysis set (FAS) population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time point.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    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
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    192 [2]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 192)
    38.5 ± 13.9
        Change at Week 12 (n=188)
    38.5 ± 23.3
    Notes
    [2] - Number of subjects analysed are the subjects who were evaluated for this endpoint.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Score of All Domains of TSQM-9 at Week 24

    Close Top of page
    End point title
    Change from Baseline in the Score of All Domains of TSQM-9 at Week 24
    End point description
    TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by subjects, by means of a subject i-PAD at each study visit. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    192 [3]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline: Convenience satisfaction (n=192)
    38.5 ± 13.9
        Change at Week 24: Convenience satisfaction(n=176)
    41.9 ± 22.5
        Baseline: Effectiveness (n=192)
    47.0 ± 17.5
        Change at Week 24: Effectiveness(n=176)
    21.2 ± 26.9
        Baseline: Global satisfaction (n=192)
    41.4 ± 17.3
        Change at Week 24: Global satisfaction (n=176)
    27.9 ± 26.1
    Notes
    [3] - Number of subjects analysed are the subjects who were evaluated for this endpoint.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Number of Subjects with Adherence to Study Treatment at Weeks 12 and 24

    Close Top of page
    End point title
    Change from Baseline in Number of Subjects with Adherence to Study Treatment at Weeks 12 and 24
    End point description
    Adherence to treatment was evaluated using a questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. Subjects who had taken the prescribed doses of treatment in the previous 28 days were evaluated. FAS population included all enrolled subjects who took at least one dose of the study medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    113 [4]
    Units: subjects
        Baseline
    113
        Change at Week 12
    65
        Change at Week 24
    53
    Notes
    [4] - Number of subjects analysed are the subjects who were evaluated for this endpoint.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fatigue Status Scale (FSS) Score at Week 12 and 24

    Close Top of page
    End point title
    Change from Baseline in Fatigue Status Scale (FSS) Score at Week 12 and 24
    End point description
    FSS is a questionnaire composed of nine statements on the state of fatigue experienced during the previous week. The answers are within a scale of agreement ranging from 1 to 7, where 1 represents less fatigue and 7 indicates highest fatigue. The total score was obtained summing the number given at each item and it ranges from 7 to 63. An overall score of ≥36 indicates a state of fatigue. Questionnaires were completed electronically by subjects, by means of a subject i-PAD at each study visit. Here negative values indicate improvement in FSS score from baseline. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 193)
    40.1 ± 15.6
        Change at Week 12 (n= 191)
    -4.6 ± 13.1
        Change at Week 24 (n= 176)
    -3.8 ± 13.1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24

    Close Top of page
    End point title
    Change from Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24
    End point description
    MSTCQ is a 20-item questionnaire containing two domains: injection-system satisfaction and side effects. The side-effects domain comprises of three subscales: injection site reaction (ISRs) and global side effects. All questions in the MSTCQ have a five-point response choice, with lower total scores indicating better outcomes. Questionnaires were completed electronically by subjects, by means of a subject i-PAD at each study visit. Here negative values indicate improvement in MSTCQ score from baseline. Here negative sign indicates improvement in MSTCQ score as compared to baseline. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 193)
    71.9 ± 14.0
        Change at Week 12 (n= 191)
    -16.8 ± 16.9
        Change at Week 24 (n= 176)
    -19.4 ± 17.1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Multiple Sclerosis International Quality of Life questionnaire (MusiQoL) Score at Weeks 12 and 24

    Close Top of page
    End point title
    Change from Baseline in Multiple Sclerosis International Quality of Life questionnaire (MusiQoL) Score at Weeks 12 and 24
    End point description
    MusiQoL is a self-administered questionnaire consisting of 31 items describing nine dimensions of health-related quality of life (QoL): activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system). All items are scored based on frequency/extent of an event on a five-point scale ranging from never/not at all (option 1) to always/very much (option 5). Total score is obtained by linearly transforming and standardizing on a 0-100 scale. Higher scores indicate a better level of health-related QoL for each dimension and for the global index score. Here, negative values indicate improvement in MusiQoL score from baseline. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=193)
    67.8 ± 16.5
        Change at Week 12 (n= 191)
    4.6 ± 14.89
        Change at Week 24 (n= 176)
    5.0 ± 14.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in Annualized Relapse Rate (ARR) at Week 24

    Close Top of page
    End point title
    Change from Baseline in Annualized Relapse Rate (ARR) at Week 24
    End point description
    Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. ARR was calculated as the total number of relapses for all subjects divided by the total subject-years of exposure to that treatment. Here negative sign indicates decrease in annual relapse rate as compared to baseline. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: relapse per year
    number (not applicable)
        Baseline (n= 193)
    0.15
        Change at Week 24 (n= 176)
    -0.03
    No statistical analyses for this end point

    Secondary: Percent Change in Relapse-Free Subjects at Week 24

    Close Top of page
    End point title
    Percent Change in Relapse-Free Subjects at Week 24
    End point description
    Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. Percent change in relapse-free subjects had been calculated with respect to the number of relapse-free subjects at baseline. Here, negative sign indicates decrease in number of relapse-free subjects at specified timepoint as compared to baseline. FAS population included all enrolled subjects who took at least one dose of the study medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    189 [5]
    Units: percent change
        number (not applicable)
    -7.94
    Notes
    [5] - Number of subjects analysed is the subjects who were evaluated for this endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AE)

    Close Top of page
    End point title
    Number of Subjects With Adverse Events (AE)
    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 AE can herefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. FAS population included all enrolled subjects who took at least one dose of the study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: subjects
    82
    No statistical analyses for this end point

    Secondary: Number of Subjects with AE Stratified by Severity

    Close Top of page
    End point title
    Number of Subjects with AE Stratified by Severity
    End point description
    Severity of AEs was evaluated based on the following criteria- Mild: Symptoms barely noticeable to subject or does not make subject uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of subject. Moderate: Symptoms of a sufficient severity to make subject uncomfortable; performance of daily activity is influenced; subject is able to continue in study; treatment for symptom(s) may be needed. Severe: Symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on subject's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or subject hospitalized. FAS population included all enrolled subjects who took at least one dose of the study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: subjects
        Mild
    55
        Moderate
    27
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Abnormal in Laboratory Values

    Close Top of page
    End point title
    Number of Subjects With Clinical Abnormal in Laboratory Values
    End point description
    Subjects with clinical abnormal laboratory values were reported throughout the studies. FAS population included all enrolled subjects who took at least one dose of the study medication. 'n' indicates the number of subjects who were evaluated at a specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Peg-interferon Beta-1a 125 μg
    Number of subjects analysed
    193
    Units: subjects
        Baseline (n= 193)
    4
        Week 12 (n= 191)
    3
        Week 24 (n= 176)
    3
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 24
    Adverse event reporting additional description
    FAS population included all enrolled subjects who took at least one dose of the study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Peg INF Beta-1a 125 μg
    Reporting group description
    Subjects received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Subjects received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.

    Serious adverse events
    Peg INF Beta-1a 125 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 193 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Peg INF Beta-1a 125 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 193 (22.80%)
    General disorders and administration site conditions
    Injection site reactions
         subjects affected / exposed
    10 / 193 (5.18%)
         occurrences all number
    12
    Influenza like illness
         subjects affected / exposed
    28 / 193 (14.51%)
         occurrences all number
    42
    Pyrexia
         subjects affected / exposed
    10 / 193 (5.18%)
         occurrences all number
    16

    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