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Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017) (ALLOW)

Primary Purpose

Relapsing Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

BIIB017

naproxen

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring flu-like symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 [Polman 2005]
Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0
Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening
All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.

Key Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS [Lublin and Reingold 1996]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement
History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol
History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline
Known allergy to any component of the BIIB017 formulation
An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BIIB017 plus current FLS therapy

BIIB017 plus naproxen

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01939002

First Posted

August 23, 2013

Last Updated

November 30, 2016

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01939002

Brief Title

Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)

Acronym

ALLOW

Official Title

An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Multiple Sclerosis

Keywords

flu-like symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

251 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB017 plus current FLS therapy

Arm Type

Experimental

Arm Description

Arm Title

BIIB017 plus naproxen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BIIB017

Other Intervention Name(s)

Plegridy, peginterferon beta-1a, PEGylated interferon beta-1a, PEG IFN β-1a

Intervention Type

Drug

Intervention Name(s)

naproxen

Other Intervention Name(s)

naproxen sodium, Aleve, NSAID, long-acting nonsteroidal anti-inflammatory drug

Primary Outcome Measure Information:

Title

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

Description

Time Frame

during the first 8 weeks of treatment

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

during the first 8 weeks of treatment

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Time Frame

during the first 8 weeks of treatment

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

4-week run-in period, Week 4

Title

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

Description

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.

Time Frame

4-week run-in period, Week 4

Title

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

Description

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.

Time Frame

4-week run-in period, Week 4

Title

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

Description

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.

Time Frame

4-week run-in period, Week 4

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Day 1 to Week 52

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 [Polman 2005] Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0 Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. Key Exclusion Criteria: Primary progressive, secondary progressive, or progressive relapsing MS [Lublin and Reingold 1996]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline Known allergy to any component of the BIIB017 formulation An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Research Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Research Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Research Site

City

Dover

State/Province

Delaware

ZIP/Postal Code

19901

Country

United States

Facility Name

Research Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Research Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Massachusetts

ZIP/Postal Code

02421

Country

United States

Facility Name

Research Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Research Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68521

Country

United States

Facility Name

Research Site

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Facility Name

Research Site

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Research Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Research Site

City

Uniontown

State/Province

Ohio

ZIP/Postal Code

44685

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Research Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37934

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Research Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

Research Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)

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Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017) (ALLOW)

Relapsing Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial