Trial Outcomes & Findings for Plegridy Satisfaction Study in Participants (NCT NCT02587065)

NCT ID: NCT02587065

Last Updated: 2023-08-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 193 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2023-08-31

Participant Flow

Participants were recruited from 32 sites in Italy.

A total of 193 participants with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study.

Participant milestones

Measure	Peg-interferon Beta-1a 125 μg 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 Study STARTED	193
Overall Study COMPLETED	166
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Peg-interferon Beta-1a 125 μg 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 Study Adverse Event	14
Overall Study Withdrawal of Informed Consent (IC)	5
Overall Study Non-adherence to the Protocol	3
Overall Study Discontinuation of Study Medication	2
Overall Study Reason not Specified	3

Baseline Characteristics

Plegridy Satisfaction Study in Participants

Baseline characteristics by cohort

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	193 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.0 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	192 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 Baseline	38.5 score on a scale Standard Deviation 13.9
Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 Change at Week 12	38.5 score on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Baseline: Convenience Satisfaction	38.5 score on a scale Standard Deviation 13.9
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Change at Week 24: Convenience Satisfaction	41.9 score on a scale Standard Deviation 22.5
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Change at Week 24: Effectiveness	21.2 score on a scale Standard Deviation 26.9
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Baseline: Global satisfaction	41.4 score on a scale Standard Deviation 17.3
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Change at Week 24: Global satisfaction	27.9 score on a scale Standard Deviation 26.1
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 Baseline: Effectiveness	47.0 score on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=113 Participants 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.
Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 Baseline	113 participants
Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 Change at Week 12	65 participants
Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 Change at Week 24	53 participants

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 Change at Week 12	-4.6 score on a scale Standard Deviation 13.1
Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 Change at Week 24	-3.8 score on a scale Standard Deviation 13.1
Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 Baseline	40.1 score on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 Baseline	71.9 score on a scale Standard Deviation 14.0
Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 Change at Week 12	-16.8 score on a scale Standard Deviation 16.9
Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 Change at Week 24	-19.4 score on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 Baseline	67.8 score on a scale Standard Deviation 16.5
Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 Change at Week 12	4.6 score on a scale Standard Deviation 14.89
Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 Change at Week 24	5.0 score on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 Baseline	0.15 relapses per participant-year
Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 Change at Week 24	-0.03 relapses per participant-year

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=189 Participants 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.
Percent Change in Relapse-Free Participants at Week 24	-7.94 percentage change

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: FAS population included all enrolled participants who took at least one dose of the study medication.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Number of Participants With Adverse Events (AE)	82 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: FAS population included all enrolled participants who took at least one dose of the study medication.

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.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Number of Participants With AE Stratified by Severity Mild	55 Participants
Number of Participants With AE Stratified by Severity Moderate	27 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: 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.

Participants with clinical abnormal laboratory values were reported throughout the studies.

Outcome measures

Measure	Peg-interferon Beta-1a 125 μg n=193 Participants 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.
Number of Participants With Clinical Abnormal Laboratory Values Baseline	4 Participants
Number of Participants With Clinical Abnormal Laboratory Values Week 12	3 Participants
Number of Participants With Clinical Abnormal Laboratory Values Week 24	3 Participants

Adverse Events

Peg-interferon Beta-1a 125 μg

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Peg-interferon Beta-1a 125 μg n=193 participants at risk 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.
General disorders Influenza like illness	14.5% 28/193 • Number of events 42 • Baseline up to Week 24 FAS population included all enrolled participants who took at least one dose of the study medication.
General disorders Injection site reactions	5.2% 10/193 • Number of events 12 • Baseline up to Week 24 FAS population included all enrolled participants who took at least one dose of the study medication.
General disorders Pyrexia	5.2% 10/193 • Number of events 16 • Baseline up to Week 24 FAS population included all enrolled participants who took at least one dose of the study medication.

Additional Information

Biogen Study Medical Director

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER