PLATINUM: Plegridy Satisfaction Study in Participants

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02587065
• Collaborator: (none)
• Enrollment: 193
• Locations: 30
• Arm: 1
• Actual Duration (Months): 22.6
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-Remitting Multiple Sclerosis (RRMS)	Drug: peginterferon beta-1a	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Feb 3, 2016
• Actual Primary Completion Date: Oct 2, 2017
• Actual Study Completion Date: Dec 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
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: BIIB017 PEGylated Interferon Beta-1a Plegridy PEG IFN β-1a

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 [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.

2. Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 [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.

3. Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 [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.

4. Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 [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.

5. Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 [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.

6. Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 [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.

7. Percent Change in Relapse-Free Participants at Week 24 [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.

8. Number of Participants With Adverse Events (AE) [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.

9. Number of Participants With AE Stratified by Severity [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.

10. Number of Participants With Clinical Abnormal Laboratory Values [Baseline up to Week 24]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Arezzo		Italy	52100
2	Research Site	Bari		Italy	70124
3	Research Site	Cagliari		Italy	09126
4	Research Site	Cefalù		Italy	90015
5	Research Site	Chieti		Italy	66100
6	Research Site	Como		Italy	22100
7	Research Site	Fidenza		Italy	43036
8	Research Site	Foligno		Italy	06034
9	Research Site	Gallarate		Italy	21013
10	Research Site	Genova		Italy	16132
11	Research Site	L'Aquila		Italy	67100
12	Research Site	Messina		Italy	98125
13	Research Site	Milano		Italy	20132
14	Research Site	Milano		Italy	20133
15	Research Site	Modena		Italy	41126
16	Research Site	Mondovì		Italy	12084
17	research Site	Napoli		Italy	80131
18	Research Site	Napoli		Italy	80137
19	Research Site	Orbassano		Italy	10043
20	Research Site	Ozieri		Italy	07014
21	Research Site	Palermo		Italy	90129
22	Research Site	Palermo		Italy	90146
23	Research Site	Pavia		Italy	27100
24	Research Site	Pietra Ligure		Italy	17027
25	Research Site	Pozzilli		Italy	86077
26	Research Site	Reggio Calabria		Italy	89100
27	Research Site	Roma		Italy	00152
28	Research Site	Roma		Italy	00168
29	Research Site	Roma		Italy	00189
30	Research Site	Torino		Italy	10126

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

• Statistical Analysis Plan - May 3, 2018
• Study Protocol - Jul 28, 2015

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT02587065
• Other Study ID Numbers: ITA-PEG-14-10779; 2015-002201-11
• First Posted: Oct 27, 2015
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Interferons; Interferon-beta; Interferon beta-1a

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 32 sites in Italy.
Pre-assignment Detail	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

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 Participants	193
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	193 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.0 (10.6)
Sex: Female, Male (Count of Participants)
Female	135 69.9%
Male	58 30.1%
Race/Ethnicity, Customized (Count of 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.
Measure Participants	193
Baseline	38.5 (13.9)
Change at Week 12	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
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Mixed-effects REML regression
	Comments
Method of Estimation	Estimation Parameter	Spearman's correlation coefficient
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -3.72 to 2.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

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.
Measure Participants	193
Baseline: Convenience Satisfaction	38.5 (13.9)
Change at Week 24: Convenience Satisfaction	41.9 (22.5)
Baseline: Effectiveness	47.0 (17.5)
Change at Week 24: Effectiveness	21.2 (26.9)
Baseline: Global satisfaction	41.4 (17.3)
Change at Week 24: Global satisfaction	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.
Measure Participants	113
Baseline	113 58.5%
Change at Week 12	65 33.7%
Change at Week 24	53 27.5%

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.
Measure Participants	193
Baseline	40.1 (15.6)
Change at Week 12	-4.6 (13.1)
Change at Week 24	-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.
Measure Participants	193
Baseline	71.9 (14.0)
Change at Week 12	-16.8 (16.9)
Change at Week 24	-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.
Measure Participants	193
Baseline	67.8 (16.5)
Change at Week 12	4.6 (14.89)
Change at Week 24	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.
Measure Participants	193
Baseline	0.15
Change at Week 24	-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.
Measure Participants	189
Number [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.
Measure Participants	193
Count of Participants [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.
Measure Participants	193
Mild	55 28.5%
Moderate	27 14%

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.
Measure Participants	193
Baseline	4 2.1%
Week 12	3 1.6%
Week 24	3 1.6%

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 (%)	# Events
Total	0/193 (0%)
Serious Adverse Events
	Peg-interferon Beta-1a 125 μg
	Affected / at Risk (%)	# Events
Total	0/193 (0%)
Other (Not Including Serious) Adverse Events
	Peg-interferon Beta-1a 125 μg
	Affected / at Risk (%)	# Events
Total	44/193 (22.8%)
General disorders
Influenza like illness	28/193 (14.5%)	42
Injection site reactions	10/193 (5.2%)	12
Pyrexia	10/193 (5.2%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.