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Trial record 2 of 4 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
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis (RRMS) Drug: peginterferon beta-1a Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 19, 2016
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: peginterferon beta-1a
125 μg administered subcutaneously (SC) every 2 weeks
Drug: peginterferon beta-1a
125 mcg administered subcutaneously (SC) every 2 weeks.
Other Names:
  • BIIB017
  • PEGylated Interferon Beta-1a
  • Plegridy
  • PEG IFN β-1a




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes from baseline in the score of all domains of TSQM-9 [ Time Frame: Baseline to Week 24 ]
  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Changes from baseline in clinical measures as assessed by percentage of relapse-free participants [ Time Frame: Week 24 ]
  8. 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.

  9. Incidence and severity of adverse events [ Time Frame: Baseline to Week 24 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587065


Locations
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Italy
Research Site
Arezzo, Italy, 52100
Research Site
Bari, Italy, 70124
Research Site
Cagliari, Italy, 09126
Research Site
Cefalù, Italy, 90015
Research Site
Chieti, Italy, 66100
Research Site
Como, Italy, 22100
Research Site
Fidenza, Italy, 43036
Research Site
Foligno, Italy, 06034
Research Site
Gallarate, Italy, 21013
Research Site
Genova, Italy, 16132
Research Site
L'Aquila, Italy, 67100
Research Site
Messina, Italy, 98125
Research Site
Milano, Italy, 20132
Research Site
Milano, Italy, 20133
Research Site
Modena, Italy, 41126
Research Site
Mondovì, Italy, 12084
research Site
Napoli, Italy, 80131
Research Site
Napoli, Italy, 80137
Research Site
Orbassano, Italy, 10043
Research Site
Ozieri, Italy, 07014
Research Site
Palermo, Italy, 90129
Research Site
Palermo, Italy, 90146
Research Site
Pavia, Italy, 27100
Research Site
Pietra Ligure, Italy, 17027
Research Site
Pozzilli, Italy, 86077
Research Site
Reggio Calabria, Italy, 89100
Research Site
Roma, Italy, 00152
Research Site
Roma, Italy, 00168
Research Site
Roma, Italy, 00189
Research Site
Torino, Italy, 10126
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02587065     History of Changes
Other Study ID Numbers: ITA-PEG-14-10779
2015-002201-11 ( EudraCT Number )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic