Plegridy Satisfaction Study in Participants (PLATINUM)

• 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: Biogen
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Peg-interferon Beta-1a 125 μg
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
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%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Participants with clinical abnormal laboratory values were reported throughout the studies.
Time Frame	Baseline up to Week 24

Outcome Measure Data

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
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%

Adverse Events

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
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%)
Serious Adverse Events
	Peg-interferon Beta-1a 125 μg
	Affected / at Risk (%)	# Events
Total	0/193 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Biogen Study Medical Director
• Organization: Biogen
• Phone: 866-633-4636
• EMail: clinicaltrials@biogen.com

• 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