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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis (RRMS)
Intervention Drug: peginterferon beta-1a
Enrollment 193
Recruitment Details Participants were recruited from 32 sites in Italy.
Pre-assignment Details A total of 193 participants with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Period Title: Overall Study
Started 193
Completed 166
Not Completed 27
Reason Not Completed
Adverse Event             14
Withdrawal of Informed Consent (IC)             5
Non-adherence to the Protocol             3
Discontinuation of Study Medication             2
Reason not Specified             3
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Baseline Participants 193
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) population included all enrolled participants who took at least one dose of the study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants
<=18 years
0
   0.0%
Between 18 and 65 years
193
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants
42.0  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants
Female
135
  69.9%
Male
58
  30.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants
Caucasian
192
  99.5%
Other
1
   0.5%
1.Primary Outcome
Title Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12
Hide 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 participants, by means of a participant i-PAD at each study visit.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 192 participants
38.5  (13.9)
Change at Week 12 Number Analyzed 188 participants
38.5  (23.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peg-interferon Beta-1a 125 μg
Comments Adjusted change of convenience satisfaction domain of TSQM-9.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Mixed-effects REML regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman's correlation coefficient
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-3.72 to 2.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Score of All Domains of TSQM-9 at Week 24
Hide 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 participants, by means of a participant i-PAD at each study visit.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline: Convenience Satisfaction Number Analyzed 176 participants
38.5  (13.9)
Change at Week 24: Convenience Satisfaction Number Analyzed 176 participants
41.9  (22.5)
Baseline: Effectiveness Number Analyzed 176 participants
47.0  (17.5)
Change at Week 24: Effectiveness Number Analyzed 193 participants
21.2  (26.9)
Baseline: Global satisfaction Number Analyzed 193 participants
41.4  (17.3)
Change at Week 24: Global satisfaction Number Analyzed 193 participants
27.9  (26.1)
3.Secondary Outcome
Title Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24
Hide Description 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.
Time Frame Baseline, Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Overall number of participants analyzed are the participants who were evaluated for the outcome measure.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
Baseline 113
Change at Week 12 65
Change at Week 24 53
4.Secondary Outcome
Title Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24
Hide 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 participants, by means of a participant i-PAD at each study visit. Here, negative values indicate improvement in FSS score from baseline.
Time Frame Baseline, Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time-point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 193 participants
40.1  (15.6)
Change at Week 12 Number Analyzed 191 participants
-4.6  (13.1)
Change at Week 24 Number Analyzed 176 participants
-3.8  (13.1)
5.Secondary Outcome
Title Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24
Hide Description 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.
Time Frame Baseline, Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 193 participants
71.9  (14.0)
Change at Week 12 Number Analyzed 191 participants
-16.8  (16.9)
Change at Week 24 Number Analyzed 176 participants
-19.4  (17.1)
6.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24
Hide 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.
Time Frame Baseline, Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 193 participants
67.8  (16.5)
Change at Week 12 Number Analyzed 191 participants
4.6  (14.89)
Change at Week 24 Number Analyzed 176 participants
5.0  (14.2)
7.Secondary Outcome
Title Change From Baseline in Annualized Relapse Rate (ARR) at Week 24
Hide 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 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Measure Type: Number
Unit of Measure: relapses per participant-year
Baseline Number Analyzed 193 participants
0.15
Change at Week 24 Number Analyzed 176 participants
-0.03
8.Secondary Outcome
Title Percent Change in Relapse-Free Participants at Week 24
Hide 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 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number of participants analyzed are the participants who were evaluable for this outcome measure.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: percentage change
-7.94
9.Secondary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Measure Type: Count of Participants
Unit of Measure: Participants
82
  42.5%
10.Secondary Outcome
Title Number of Participants With AE Stratified by Severity
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
55
  28.5%
Moderate
27
  14.0%
11.Secondary Outcome
Title Number of Participants With Clinical Abnormal Laboratory Values
Hide Description Participants with clinical abnormal laboratory values were reported throughout the studies.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description:
Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
Overall Number of Participants Analyzed 193
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 193 participants
4
   2.1%
Week 12 Number Analyzed 191 participants
3
   1.6%
Week 24 Number Analyzed 176 participants
3
   1.7%
Time Frame Baseline up to Week 24
Adverse Event Reporting Description FAS population included all enrolled participants who took at least one dose of the study medication.
 
Arm/Group Title Peg-interferon Beta-1a 125 μg
Hide Arm/Group Description Participants 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. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
All-Cause Mortality
Peg-interferon Beta-1a 125 μg
Affected / at Risk (%)
Total   0/193 (0.00%)    
Hide Serious Adverse Events
Peg-interferon Beta-1a 125 μg
Affected / at Risk (%) # Events
Total   0/193 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peg-interferon Beta-1a 125 μg
Affected / at Risk (%) # Events
Total   44/193 (22.80%)    
General disorders   
Influenza like illness  1  28/193 (14.51%)  42
Injection site reactions  1  10/193 (5.18%)  12
Pyrexia  1  10/193 (5.18%)  16
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02587065    
Other Study ID Numbers: ITA-PEG-14-10779
2015-002201-11 ( EudraCT Number )
First Submitted: October 23, 2015
First Posted: October 27, 2015
Results First Submitted: October 16, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020