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
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Summary
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EudraCT number |
2015-002201-11 |
Trial protocol |
IT |
Global end of trial date |
21 Dec 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Nov 2019
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First version publication date |
02 Nov 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ITA-PEG-14-10779
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02587065 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Biogen
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Sponsor organisation address |
225 Binney Street, Cambridge, Massachusetts,, United States, 02142
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Public contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Scientific contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Dec 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Dec 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
03 Feb 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 193
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Worldwide total number of subjects |
193
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EEA total number of subjects |
193
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
193
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 32 sites in Italy. | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 193 subjects with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
Peg INF beta-1a, Plegridy®
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Single 125 μg Peg-interferon beta-1a subcutaneously every two weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Peg-interferon Beta-1a 125 μg
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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. | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Peg-interferon Beta-1a 125 μg
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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. | ||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Week 12
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| 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. |
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| Notes [2] - Number of subjects analysed are the subjects who were evaluated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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| Notes [3] - Number of subjects analysed are the subjects who were evaluated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24
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| Notes [4] - Number of subjects analysed are the subjects who were evaluated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24
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| No statistical analyses for this end point | |||||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24
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| No statistical analyses for this end point | |||||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24
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| No statistical analyses for this end point | |||||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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| Notes [5] - Number of subjects analysed is the subjects who were evaluated for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 24
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| No statistical analyses for this end point | |||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 24
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| No statistical analyses for this end point | |||||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 24
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to Week 24
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Adverse event reporting additional description |
FAS population included all enrolled subjects who took at least one dose of the study medication.
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Assessment type |
Systematic | ||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Peg INF Beta-1a 125 μg
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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. | ||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
