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Trial record 2 of 5 for:    Plegridy | Multiple Sclerosis | Italy

Plegridy Satisfaction Study in Participants (PLATINUM)

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ClinicalTrials.gov Identifier: NCT02587065
Recruitment Status : Completed
First Posted : October 27, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE October 27, 2015
Results First Submitted Date  ICMJE October 16, 2019
Results First Posted Date  ICMJE January 13, 2020
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE February 3, 2016
Actual Primary Completion Date October 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 [ Time Frame: Baseline, Week 12 ]
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 participants, by means of a participant i-PAD at each study visit.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
Changes from baseline in the score of convenience satisfaction domain of TSQM-9 [ Time Frame: Baseline to Week 12 ]
The TSQM Version 1.4 is a 14-item consisting of four scales: the effectiveness scale (questions 1 to 3), the side effects scale (questions 4 to 8), the convenience scale (questions 9 to 11) and the global satisfaction scale (questions 12 to 14). The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 [ Time Frame: Baseline, Week 24 ]
    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 participants, by means of a participant i-PAD at each study visit.
  • Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    Adherence to treatment was evaluated using a questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. Participants who had taken the prescribed doses of treatment in the previous 28 days were evaluated.
  • Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    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 participants, by means of a participant i-PAD at each study visit. Here, negative values indicate improvement in FSS score from baseline.
  • Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    MSTCQ is a 20-item questionnaire adapted for 'Peg-interferon Beta 1a' containing two domains: injection system satisfaction (1-9) and side effects (1-11). All questions in the MSTCQ have a five-point response choice, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicating better outcomes. Questionnaires were completed electronically by participants, by means of a participant I-PAD at each study visit. Here, negative values indicate improvement in MSTCQ score from baseline.
  • Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    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.
  • Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 [ Time Frame: Baseline, Week 24 ]
    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 participants divided by the total participant-years of exposure to that treatment. Here negative sign indicates decrease in annual relapse rate as compared to baseline.
  • Percent Change in Relapse-Free Participants at Week 24 [ Time Frame: Baseline, Week 24 ]
    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 participants had been calculated with respect to the number of relapse-free participants at baseline. Here, negative sign indicates decrease in number of relapse free participants at specified timepoint as compared to baseline.
  • Number of Participants With Adverse Events (AE) [ Time Frame: Baseline up to Week 24 ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant 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.
  • Number of Participants With AE Stratified by Severity [ Time Frame: Baseline up to Week 24 ]
    Severity of AEs was evaluated based on the following criteria- Mild: Symptoms barely noticeable to participant or does not make participant 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 participant. Moderate: Symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant 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 participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized.
  • Number of Participants With Clinical Abnormal Laboratory Values [ Time Frame: Baseline up to Week 24 ]
    Participants with clinical abnormal laboratory values were reported throughout the studies.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • Changes from baseline in the score of all domains of TSQM-9 [ Time Frame: Baseline to Week 24 ]
  • Changes from baseline in participant adherence to study treatment survey [ Time Frame: Week 12 and Week 24 ]
    A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.
  • Changes from baseline in the score of FSS (Fatigue Status Scale) [ Time Frame: Week 12 and Week 24 ]
    This is a specific questionnaire composed of 9 statements on the state of fatigue during the previous week. The answers are within a scale of agreement ranging from 1 to 7, with 1 representing the lowest level of agreement. An overall score of ≥36 indicates a state of fatigue.
  • Changes from baseline in the score of Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) [ Time Frame: Week 12 and Week 24 ]
    The MSTCQ is a validated 20-item participant questionnaire developed to address participant concerns with IFN-beta treatment that are not related to efficacy. It has two domains: injection-system satisfaction and side effects. All questions in the MSTCQ have a 5-point response choice, with lower total scores indicating better outcomes.
  • Changes from baseline in the score of Multiple Sclerosis International Quality of Life questionnaire (MusiQoL) [ Time Frame: Week 12 and Week 24 ]
    MusiQoL version 5.2 is a multi-dimensional self-administered questionnaire consisting of 31 items describing nine dimensions of health-related quality of life. The nine dimensions assess many aspect of QoL that are specific to MS participants (activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system). All of the 9 dimensions and the global index are linearly transformed and standardized on a 0-100 scale with higher scores indicating better QoL.
  • Changes from baseline in clinical measures as assessed by Annualized Relapse Rate (ARR) [ Time Frame: Week 24 ]
    Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event.
  • Changes from baseline in clinical measures as assessed by percentage of relapse-free participants [ Time Frame: Week 24 ]
  • Changes from baseline in clinical measures as assessed by EDSS (Expanded Disability Status Scale) score [ Time Frame: Week 24 ]
    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.
  • Incidence and severity of adverse events [ Time Frame: Baseline to Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plegridy Satisfaction Study in Participants
Official Title  ICMJE Multicenter 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 (PLATINUM)
Brief Summary The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate the treatment safety and tolerability.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis (RRMS)
Intervention  ICMJE Drug: peginterferon beta-1a
125 mcg administered subcutaneously (SC) every 2 weeks.
Other Names:
  • BIIB017
  • PEGylated Interferon Beta-1a
  • Plegridy
  • PEG IFN β-1a
Study Arms  ICMJE Experimental: peginterferon beta-1a
125 μg administered subcutaneously (SC) every 2 weeks
Intervention: Drug: peginterferon beta-1a
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2019)
193
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2015)
275
Actual Study Completion Date  ICMJE December 21, 2017
Actual Primary Completion Date October 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.
  • Subjects with EDSS score between 0.0 and 5.0 at baseline.

Key Exclusion Criteria:

  • Pregnancy or breast-feeding.
  • Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02587065
Other Study ID Numbers  ICMJE ITA-PEG-14-10779
2015-002201-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP