Plegridy Satisfaction Study in Participants (PLATINUM)

August 18, 2023 updated by: Biogen

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • 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, 90146
        • Research Site
      • Palermo, Italy, 90129
        • 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, 00168
        • Research Site
      • Roma, Italy, 00152
        • Research Site
      • Roma, Italy, 00189
        • Research Site
      • Torino, Italy, 10126
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Plegridy
  • PEG IFN β-1a
  • BIIB017
  • PEGylated Interferon Beta-1a

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 24
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.
Baseline, Weeks 12 and 24
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.
Baseline, Weeks 12 and 24
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.
Baseline, Weeks 12 and 24
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.
Baseline, Weeks 12 and 24
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
Baseline up to Week 24
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.
Baseline up to Week 24
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.
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITA-PEG-14-10779
  • 2015-002201-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings