Characterize Flu-like Symptoms in Relapsing Multiple Scle... | NCT01939002

Characterize Flu-like Symptoms in Relapsing Multiple Scle... | NCT01939002 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIIB017 plus current FLS therapy	Experimental	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.	Drug: BIIB017
BIIB017 plus naproxen	Experimental	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.	Drug: BIIB017 Drug: naproxen

Name	Type	Description	Arm Group Labels	Other Names
BIIB017	Drug		BIIB017 plus current FLS therapy BIIB017 plus naproxen	Plegridy peginterferon beta-1a

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population	The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.	during the first 8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms	The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gilbert	Arizona	85234	United States
Research Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
BG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00049.76± 10.32 BG00149.88± 9.45 BG00249.82± 9.88

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00084 BG00179 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population

The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Number

percentage of participants

during the first 8 weeks of treatment

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Units	Counts
Participants	OG000194

Title

Denominators

Categories

Title	Measurements
	OG00010.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Chi-squared		<0.0001	1-sample Chi-square test comparing to Null hypotheses at 25%.												No	Superiority or Other

Secondary

Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms

The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Number

percentage of participants

during the first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Number

percentage of participants

4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Number

percentage of participants

4-week run-in period, first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Number

percentage of participants

4-week run-in period, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of Average Duration of FLS in the First 8 Weeks of Treatment

Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.

Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.

Posted

Median

Full Range

hours

4-week run-in period, first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen

Secondary

Summary of Average Duration of FLS in the 48 Weeks of Treatment

Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.

Posted

Median

Full Range

hours

4-week run-in period, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment

Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment

Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment

Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, 48 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS

Posted

Number

percentage of participants

during the first 8 weeks of treatment

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Week 4

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Week 4

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Week 4

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

units on a scale

4-week run-in period, Week 4

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Secondary

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population

Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.

Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.

Posted

Mean

Standard Deviation

days

Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population

Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.

Posted

Mean

Standard Deviation

days

Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population

Posted

Mean

Standard Deviation

days

Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population

Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.

Posted

Mean

Standard Deviation

units on a scale

Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Units	Counts

Secondary

Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs

An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.

Safety population: all participants who received at least 1 injection of study treatment.

Posted

Number

participants

Day 1 to Week 52

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
OG001	BIIB017 Plus Naproxen	BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Secondary

Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period

Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.

Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.

Posted

Mean

Standard Deviation

hours

Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)

ID	Title	Description
OG000	BIIB017 Plus Current FLS Therapy	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
OG001	BIIB017 Plus Naproxen

Secondary

Antibody Data in the Overall Population: IFN β-1a Antibody Screening

The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.

Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.

Posted

Number

participants

Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Units	Counts
Participants

Secondary

Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing

The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.

Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.

Posted

Number

participants

Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Units	Counts
Participants

Secondary

Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing

The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.

Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.

Posted

Number

participants

Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

ID	Title	Description
OG000	Overall Population	Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus: current FLS management regimen as determined by the clinician; or 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BIIB017 Plus Current FLS Therapy	BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician			4	103	92	103
EG001	BIIB017 Plus Naproxen	BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently			6	98	90	98

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Abscess limb	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected103 at risk EG0011 affected98 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0010 affected98 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site erythema	General disorders	MedDRA 18.0	Systematic Assessment	EG00046 affected103 at risk EG00134 affected98 at risk
Injection site reaction	General disorders	MedDRA 18.0	Systematic Assessment	EG00023 affected103 at risk EG00121 affected98 at risk
Influenza like illness	General disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected103 at risk EG00113 affected98 at risk
Injection site pruritus	General disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected103 at risk EG0017 affected98 at risk
Injection site pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected103 at risk EG0013 affected98 at risk
Injection site bruising	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected103 at risk EG0016 affected98 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected103 at risk EG0016 affected98 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected103 at risk EG0016 affected98 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected103 at risk EG0011 affected98 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected103 at risk EG00110 affected98 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected103 at risk EG00110 affected98 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00010 affected103 at risk EG0014 affected98 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected103 at risk EG0016 affected98 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected103 at risk EG0017 affected98 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected103 at risk EG0017 affected98 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected103 at risk EG0011 affected98 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected103 at risk EG0016 affected98 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected103 at risk EG0016 affected98 at risk

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000893	Anti-Inflammatory Agents
D045506	Therapeutic Uses
D018501	Antirheumatic Agents

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.2037	Chi-square test between 2 treatment arms.												No	Superiority or Other

Title

Denominators

Categories

With FLS in 4WRI / With FLS during F8W

Title	Measurements
	OG00085.00 OG00182.98 OG00284.02

With FLS in 4WRI / Without FLS during F8W

Title	Measurements
	OG0003.00 OG0018.51 OG0025.67

Without FLS in 4WRI / With FLS during F8W

Title	Measurements
	OG0006.00 OG0015.32 OG0025.67

Without FLS in 4WRI / Without FLS during F8W

Title	Measurements
	OG0006.00 OG0013.19 OG0024.64

Group IDs	Statistical Method	Statistical Comment	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG002	McNemar	McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.	1.00	No	Superiority or Other
OG000	McNemar		0.5078	No	Superiority or Other
OG001	McNemar		0.5811	No	Superiority or Other

Title

Denominators

Categories

With FLS in 4WRI / With FLS during 48W

Title	Measurements
	OG00086.00 OG00187.23 OG00286.60

With FLS in 4WRI / Without FLS during 48W

Title	Measurements
	OG0002.00 OG0014.26 OG0023.09

Without FLS in 4WRI / With FLS during 48W

Title	Measurements
	OG0009.00 OG0017.45 OG0028.25

Without FLS in 4WRI / Without FLS during 48W

Title	Measurements
	OG0003.00 OG0011.06 OG0022.06

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG002	McNemar	0.0525	No	Superiority or Other
OG000	McNemar	0.0654	No	Superiority or Other
OG001	McNemar	0.5488	No	Superiority or Other

Title

Denominators

Categories

Severity of FLS in 4WRI

Title	Measurements
	OG0001.198± 1.224 OG0011.05± 1.02 OG0021.126± 1.129

Severity of FLS in F8W

Title	Measurements
	OG0001.311± 1.185 OG0011.036± 0.951 OG0021.178± 1.084

Mean Change from 4WRI to F8W

Title	Measurements
	OG0000.113± 0.67 OG001-0.013± 0.581 OG0020.052± 0.63

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0945	No	Superiority or Other
OG001	paired t-test within 1 arm	0.8246	No	Superiority or Other
OG002	paired t-test within 1 arm	0.2533	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.1631	No	Superiority or Other

Title

Denominators

Categories

Severity of FLS in 4WRI

Title	Measurements
	OG0001.2± 1.22 OG0011.05± 1.02 OG0021.13± 1.13

Severity of FLS in 48W

Title	Measurements
	OG0001.28± 1.19 OG0010.98± 1.00 OG0021.14± 1.11

Mean Change from 4WRI to 48W

Title	Measurements
	OG0000.08± 0.83 OG001-0.07± 0.7 OG0020.01± 0.77

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.3189	No	Superiority or Other
OG001	paired t-test within 1 arm	0.3582	No	Superiority or Other
OG002	paired t-test within 1 arm	0.8484	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.1771	No	Superiority or Other

Title

Denominators

Categories

Average duration in 4WRI; n=88, 86, 174

Title	Measurements
	OG00016(6 to 33.38) OG00112.8(6 to 42.86) OG00213.75(6 to 42.86)

Average duration in F8W; n=91, 83, 174

Title	Measurements
	OG00018(6 to 40.8) OG00118(6 to 43.5) OG00218(6 to 43.5)

Change from 4WRI to F8W; n=85, 78, 163

Title	Measurements
	OG0002.1(-16.5 to 18.4) OG0013.8(-10.5 to 20.4) OG0023(-16.5 to 20.4)

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0009	No	Superiority or Other
OG001	paired t-test within 1 arm	<0.0001	No	Superiority or Other
OG002	paired t-test within 1 arm	<0.0001	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.3792	No	Superiority or Other

Title

Denominators

Categories

Average duration in 4WRI; n=88, 86, 174

Title	Measurements
	OG00016(6 to 33.38) OG00112.8(6 to 42.86) OG00213.75(6 to 42.86)

Average duration in 48W; n=95, 89, 184

Title	Measurements
	OG00016.75(6 to 38.09) OG00116.96(6 to 39) OG00216.96(6 to 39)

Change from 4WRI to 48W; n=86, 82, 168

Title	Measurements
	OG0002.82(-19.57 to 17.83) OG0012(-10 to 14.88) OG0022.16(-19.57 to 17.83)

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0019	No	Superiority or Other
OG001	paired t-test within 1 arm	0.0009	No	Superiority or Other
OG002	paired t-test within 1 arm	<0.0001	No	Superiority or Other

Title

Denominators

Categories

Effectiveness in 4WRI; n=91, 86, 177

Title	Measurements
	OG00064.5± 27.952 OG00166.398± 28.855 OG00265.422± 28.329

Effectiveness in F8W; n=96, 91, 187

Title	Measurements
	OG00069.695± 22.423 OG00174.253± 23.85 OG00271.913± 23.179

Change from 4WRI to F8W; n=87, 83, 170

Title	Measurements
	OG0006.525± 23.271 OG0015.694± 29.151 OG0026.119± 26.231

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0105	No	Superiority or Other
OG001	paired t-test within 1 arm	0.0789	No	Superiority or Other
OG002	paired t-test within 1 arm	0.0027	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.8380	No	Superiority or Other

Title

Denominators

Categories

Satisfaction in 4WRI; n=91, 86, 177

Title	Measurements
	OG00068.654± 26.574 OG00172.778± 23.817 OG00270.658± 25.285

Satisfaction in F8W; n=96, 91, 187

Title	Measurements
	OG00071.153± 21.884 OG00174.684± 23.671 OG00272.871± 22.778

Change from 4WRI to F8W; n=87, 83, 170

Title	Measurements
	OG0003.715± 23.307 OG0010.759± 24.729 OG0022.272± 23.986

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.1407	No	Superiority or Other
OG001	paired t-test within 1 arm	0.7805	No	Superiority or Other
OG002	paired t-test within 1 arm	0.2186	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.4234	No	Superiority or Other

Title

Denominators

Categories

Effectiveness in 4WRI; n=91, 86, 177

Title	Measurements
	OG00064.5± 27.952 OG00166.398± 28.855 OG00265.422± 28.329

Effectiveness in 48W; n=99, 94, 193

Title	Measurements
	OG00070.547± 21.657 OG00175.416± 21.28 OG00272.918± 21.557

Change from 4WRI to 48W; n=90, 86, 176

Title	Measurements
	OG0006.803± 24.182 OG0018.042± 27.206 OG0027.408± 25.638

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0090	No	Superiority or Other
OG001	paired t-test within 1 arm	0.0075	No	Superiority or Other
OG002	paired t-test within 1 arm	0.0002	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.7497	No	Superiority or Other

Title

Denominators

Categories

Satisfaction in 4WRI; n=91, 86, 177

Title	Measurements
	OG00068.654± 26.574 OG00172.778± 23.817 OG00270.658± 25.285

Satisfaction in 48W; n=99, 94, 193

Title	Measurements
	OG00072.192± 21.053 OG00176.061± 21.075 OG00274.076± 21.098

Change from 4WRI to 48W; n=90, 86, 176

Title	Measurements
	OG0004.607± 22.43 OG0012.274± 21.874 OG0023.467± 22.128

Group IDs	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	paired t-test within 1 arm	0.0545	No	Superiority or Other
OG001	paired t-test within 1 arm	0.3377	No	Superiority or Other
OG002	paired t-test within 1 arm	0.0391	No	Superiority or Other
OG000 OG001	2-sample t-test between 2 arms	0.4861	No	Superiority or Other

Title

Denominators

Categories

Used additional regimen, first 8 weeks; n=78, 85

Title	Measurements
	OG0006.4 OG00115.3

No additional regimen, first 8 weeks; n=78, 85

Title	Measurements
	OG00093.6 OG00184.7

Used additional regimen, Weeks 0-2; n=57, 73

Title	Measurements
	OG0001.8 OG00111

No additional regimen, Weeks 0-2; n=57, 73

Title	Measurements
	OG00098.2 OG00189

Used additional regimen, Weeks 3-4; n=61, 77

Title	Measurements
	OG0006.6 OG0015.2

No additional regimen, Weeks 3-4; n=61, 77

Title	Measurements
	OG00093.4 OG00194.8

Used additional regimen, Weeks 5-6; n=63, 76

Title	Measurements
	OG0000 OG0012.6

No additional regimen, Weeks 5-6; n=63, 76

Title	Measurements
	OG000100 OG00197.4

Used additional regimen, Weeks 7-8; n=52, 74

Title	Measurements
	OG0001.9 OG0014.1

No additional regimen, Weeks 7-8; n=52, 74

Title	Measurements
	OG00098.1 OG00195.9

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	first 8 weeks	Fisher Exact	0.0834	No	Superiority or Other
OG000 OG001	Weeks 0-2	Fisher Exact	0.0767	No	Superiority or Other
OG000 OG001	Weeks 3-4	Fisher Exact	0.7320	No	Superiority or Other
OG000 OG001	Weeks 5-6	Fisher Exact	0.5008	No	Superiority or Other
OG000 OG001	Weeks 7-8	Fisher Exact	0.6422	No	Superiority or Other

Title

Denominators

Categories

Effectiveness at 4WRI; n=194

Title	Measurements
	OG00073.871± 20.131

Change at Week 4; n=185

Title	Measurements
	OG000-2.589± 28.139

Change at Week 12; n=175

Title	Measurements
	OG000-1.274± 30.682

Change at Week 24; n=167

Title	Measurements
	OG0000.341± 27.401

Change at Week 36; n =162

Title	Measurements
	OG0001.864± 29.175

Change at Week 48; n=153

Title	Measurements
	OG0002.863± 29.172

Change at Early Termination; n=26

Title	Measurements
	OG000-17.308± 34.534

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	0.2123	No	Superiority or Other
OG000	change at Week 12	paired t-test within 1 arm	0.5834	No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	0.8723	No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	0.4173	No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.2267	No	Superiority or Other
OG000	change at Early Term	paired t-test within 1 arm	0.0171	No	Superiority or Other

Title

Denominators

Categories

Side Effects at 4WRI; n=194

Title	Measurements
	OG00085.17± 18.136

Change at Week 4; n=185

Title	Measurements
	OG0006.065± 21.243

Change at Week 12; n=175

Title	Measurements
	OG0005.109± 19.67

Change at Week 24; n=167

Title	Measurements
	OG0002.958± 18.131

Change at Week 36; n=162

Title	Measurements
	OG0003.37± 18.207

Change at Week 48; n=153

Title	Measurements
	OG0001.418± 20.922

Change at Early Termination; n=26

Title	Measurements
	OG000-18.731± 31.776

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	0.0001	No	Superiority or Other
OG000	change at Week 12	paired t-test within 1 arm	0.0007	No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	0.0365	No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	0.0197	No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.4031	No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	0.0060	No	Superiority or Other

Title

Denominators

Categories

Convenience at 4WRI; n=194

Title	Measurements
	OG00066.665± 16.588

Change at Week 4; n=185

Title	Measurements
	OG00018.703± 21.864

Change at Week 12; n=175

Title	Measurements
	OG00018.12± 20.588

Change at Week 24; n=167

Title	Measurements
	OG00018.419± 20.804

Change at Week 36; n =162

Title	Measurements
	OG00018.704± 21.258

Change at Week 48; n=153

Title	Measurements
	OG00019.588± 20.912

Change at Early Termination; n=26

Title	Measurements
	OG0007.808± 28.788

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 12	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	0.1789		No	Superiority or Other
OG000		general linear model	0.2248	p-value on slope is based on general linear model with repeat measures over all visits.	No	Superiority or Other

Title

Denominators

Categories

Global Satisfaction at 4WRI; n=194

Title	Measurements
	OG00075.985± 15.137

Change at Week 4; n=185

Title	Measurements
	OG0006.789± 19.8

Change at Week 12; n=175

Title	Measurements
	OG0007.354± 20.296

Change at Week 24; n=167

Title	Measurements
	OG0007.575± 19.91

Change at Week 36; n =162

Title	Measurements
	OG0009.179± 19.215

Change at Week 48; n=153

Title	Measurements
	OG0008.556± 23.389

Change at Early Termination; n=26

Title	Measurements
	OG000-38.538± 26.224

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 12	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	<0.0001		No	Superiority or Other
OG000		general linear model	<0.0001	p-value on slope is based on general linear model with repeat measures over all visits.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	0.7012	No	Superiority or Other
OG001	change at Week 4	paired t-test within 1 arm	0.0548	No	Superiority or Other
OG000 OG001	change at Week 4	2-sample t-test between 2 arms	0.0782	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	0.0006	No	Superiority or Other
OG001	change at Week 4	paired t-test within 1 arm	0.0792	No	Superiority or Other
OG000 OG001	change at Week 4	2-sample t-test between 2 arms	0.0961	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	<0.0001	No	Superiority or Other
OG001	change at Week 4	paired t-test within 1 arm	<0.0001	No	Superiority or Other
OG000 OG001	change at Week 4	2-sample t-test between 2 arms	0.4973	No	Superiority or Other

Title

Denominators

Categories

Global Satisfaction at 4WRI; n=100, 94

Title	Measurements
	OG00075.86± 14.001 OG00176.117± 16.334

Change at Week 4; n=95, 90

Title	Measurements
	OG0008.663± 16.633 OG0014.811± 22.596

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 4	paired t-test within 1 arm	<0.0001	No	Superiority or Other
OG001	change at Week 4	paired t-test within 1 arm	0.0464	No	Superiority or Other
OG000 OG001	change at Week 4	2-sample t-test between 2 arms	0.1905	No	Superiority or Other

Title

Denominators

Categories

Days in 4WRI; n=123

Title	Measurements
	OG0004.691± 1.033

Change at Week 12; n=106

Title	Measurements
	OG000-0.019± 0.436

Change at Week 24; n=99

Title	Measurements
	OG000-0.081± 0.566

Change at Week 36; n=96

Title	Measurements
	OG000-0.052± 0.773

Change at Week 48; n=95

Title	Measurements
	OG0000.032± 0.573

Change at Early Termination; n=15

Title	Measurements
	OG0000.2± 0.862

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 12	paired t-test within 1 arm	0.6569		No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	0.1584		No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	0.5106		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.5927		No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	0.3840		No	Superiority or Other
OG000		general linear model	0.4182	p-value on slope is based on general linear model with repeat measures over all visits.	No	Superiority or Other

Title

Denominators

Categories

Days in 4WRI; n=123

Title	Measurements
	OG0000.016± 0.127

Change at Week 12; n=106

Title	Measurements
	OG0000.057± 0.513

Change at Week 24; n=99

Title	Measurements
	OG0000.061± 0.373

Change at Week 36; n=96

Title	Measurements
	OG0000± 0.205

Change at Week 48; n =95

Title	Measurements
	OG0000.137± 1.078

Change at Early Termination; n=15

Title	Measurements
	OG0000± 0

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 12	paired t-test within 1 arm	0.2588		No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	0.1092		No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	1.0000		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.2190		No	Superiority or Other
OG000		general linear model	0.6402	p-value on slope is based on general linear model with repeat measures over all visits.	No	Superiority or Other

Title

Denominators

Categories

Days in 4WRI; n=123

Title	Measurements
	OG0000.016± 0.127

Change at Week 12; n=106

Title	Measurements
	OG0000.019± 0.275

Change at Week 24; n=99

Title	Measurements
	OG0000.02± 0.319

Change at Week 36; n=96

Title	Measurements
	OG000-0.021± 0.144

Change at Week 48; n =95

Title	Measurements
	OG0000.126± 1.074

Change at Early Termination; n=15

Title	Measurements
	OG0000.2± 0.414

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 12	paired t-test within 1 arm	0.4821		No	Superiority or Other
OG000	change at Week 24	paired t-test within 1 arm	0.5298		No	Superiority or Other
OG000	change at Week 36	paired t-test within 1 arm	0.1584		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.2547		No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	0.0824		No	Superiority or Other
OG000		general linear model	0.3148	p-value on slope is based GLM with repeat measures over all visits.	No	Superiority or Other

Title

Denominators

Categories

Baseline; n=194

Title	Measurements
	OG0000.83± 1.258

Change at Week 12; n=174

Title	Measurements
	OG0000.029± 0.836

Change at Week 48; n=153

Title	Measurements
	OG0000.15± 0.857

Change Early Termination; n=26

Title	Measurements
	OG0000.346± 1.093

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	change at Week 12	paired t-test within 1 arm	0.6508		No	Superiority or Other
OG000	change at Week 48	paired t-test within 1 arm	0.0315		No	Superiority or Other
OG000	change at Early Termination	paired t-test within 1 arm	0.1190		No	Superiority or Other
OG000		general linear model	0.1520	p-value on slope is based GLM with repeat measures over all visits.	No	Superiority or Other

Title

Denominators

Categories

Any event

Title	Measurements
	OG00093 OG00190

Moderate or severe event

Title	Measurements
	OG00054 OG00160

Severe event

Title	Measurements
	OG0007 OG00112

Related event

Title	Measurements
	OG00080 OG00171

Serious event

Title	Measurements
	OG0004 OG0016

Discontinuations due to AEs

Title	Measurements
	OG00014 OG00113

Treatment discontinuation due to FLS event

Title	Measurements
	OG0003 OG0012

Treatment discontinuation due to ISR events

Title	Measurements
	OG0005 OG0013

Study discontinuation due to an event

Title	Measurements
	OG00013 OG00113

Title

Denominators

Categories

Average duration in 4WRI; n=88, 86, 174

Title	Measurements
	OG00016.067± 8.277 OG00114.915± 7.637 OG00215.497± 7.965

Average duration in L4W; n=87, 83, 170

Title	Measurements
	OG00018.057± 9.06 OG00115.892± 8.073 OG00217± 8.635

Change from 4WRI to L4W; n=80, 77, 157

Title	Measurements
	OG0002.612± 8.067 OG0010.943± 6.738 OG0021.793± 7.468

Group IDs	Group Description	Statistical Method	P-Value	Tested Non-Inferiority	Non-Inferiority Type
OG000	Change from 4WRI to L4W	paired t-test within 1 arm	0.0049	No	Superiority or Other
OG001	Change from 4WRI to L4W	paired t-test within 1 arm	0.2230	No	Superiority or Other
OG002	Change from 4WRI to L4W	paired t-test within 1 arm	0.0031	No	Superiority or Other
OG000 OG001	Change from 4WRI to L4W	2-sample t-test between 2 arms	0.1624	No	Superiority or Other

Title

Denominators

Categories

Baseline: Positive; n=199

Title	Measurements
	OG00022

Baseline: Negative; n=199

Title	Measurements
	OG000177

Any post-baseline visit: Positive; n=198

Title	Measurements
	OG00035

Any post-baseline visit: Negative; n=198

Title	Measurements
	OG000178

Week 12: Positive; n=183

Title	Measurements
	OG00026

Week 12: Negative; n=183

Title	Measurements
	OG000157

Week 24: Positive; n=171

Title	Measurements
	OG00022

Week 24: Negative; n=171

Title	Measurements
	OG000149

Week 36: Positive; n=167

Title	Measurements
	OG00018

Week 36: Negative; n=167

Title	Measurements
	OG000149

Week 48/EW: Positive; n=193

Title	Measurements
	OG00025

Week 48/EW: Negative; n=193

Title	Measurements
	OG000168

Negative at BL with ≥ 1 positive post-BL; n=174

Title	Measurements
	OG00013

Title

Denominators

Categories

Baseline: Positive; n=201

Title	Measurements
	OG0007

Baseline: Negative; n=201

Title	Measurements
	OG000194

Any post-baseline visit: Positive; n=198

Title	Measurements
	OG0008

Any post-baseline visit: Negative; n=198

Title	Measurements
	OG000196

Week 12: Positive; n=182

Title	Measurements
	OG0006

Week 12: Negative; n=182

Title	Measurements
	OG000176

Week 24: Positive; n=173

Title	Measurements
	OG0003

Week 24: Negative; n=173

Title	Measurements
	OG000170

Week 36: Positive; n=168

Title	Measurements
	OG0001

Week 36: Negative; n=168

Title	Measurements
	OG000167

Week 48/EW: Positive; n=193

Title	Measurements
	OG0003

Week 48/EW: Negative; n=193

Title	Measurements
	OG000190

Negative at BL with ≥ 1 positive post-BL; n=192

Title	Measurements
	OG0004

Title

Denominators

Categories

Baseline: Positive; n=22

Title	Measurements
	OG00014

Baseline: Negative; n=22

Title	Measurements
	OG0008

Any post-baseline visit: Positive; n=35

Title	Measurements
	OG00017

Any post-baseline visit: Negative; n=35

Title	Measurements
	OG00020

Week 12: Positive; n=26

Title	Measurements
	OG00015

Week 12: Negative; n=26

Title	Measurements
	OG00011

Week 24: Positive; n=22

Title	Measurements
	OG00011

Week 24: Negative; n=22

Title	Measurements
	OG00011

Week 36: Positive; n=18

Title	Measurements
	OG00011

Week 36: Negative; n=18

Title	Measurements
	OG0007

Week 48/EW: Positive; n=25

Title	Measurements
	OG00012

Week 48/EW: Negative; n=25

Title	Measurements
	OG00013

Negative at BL with ≥ 1 positive post-BL; n=7

Title	Measurements
	OG0001

ID	Term
C428112	peginterferon beta-1a
D009288	Naproxen
D000894	Anti-Inflammatory Agents, Non-Steroidal