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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000434-21 | EudraCT Number |
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The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (AEs) of flu-like symptoms (FLS) [chills, pyrexia, myalgia, and asthenia], injection site reactions (ISRs), and injection site reaction pain (ISR-P), over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 microgram (μg) subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peginterferon beta-1a | Active Comparator |
| |
| Current Therapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon beta-1a | Drug | SC every 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS) | FLS as defined by chills, pyrexia, myalgia, and asthenia | Up to Week 24 |
| Combined Counts of AEs of Injection Site Reactions (ISRs) | Defined as a post-application assessment score ≥2 in participant assessments using the Patient's Erythema Self-Assessment 1 (PSA) scale | Up to Week 24 |
| Combined Counts of AEs of Injection Site Reactions (ISRs) | Defined as a post-application assessment score ≥2 in clinician assessments using the Clinician Erythema Assessment (CEA) scale | Up to Week 24 |
| Combined Counts of AEs of ISR Pain (ISRP) | Defined as visual analog scale (VAS) associated with ISR ≥1 immediately after injection or 30 minutes post-injection | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Participant-Reported Treatment Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) in Participants Treated with PLEGRIDY Versus Current SC IFN-β | A questionnaire assessing patient satisfaction with drug on 3 scales: effectiveness, convenience, and global satisfaction | Baseline to Week 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Fernando Fonseca | Amadora | 2720-276 | Portugal | |||
| Hospital de Braga |
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| interferon beta-1a | Drug | Per Summary of Product Characteristics (SMPC) |
|
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| interferon beta-1b | Drug | Per SMPC |
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| Change in Participant-Reported Treatment Satisfaction Using TSQM-9 in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period |
A questionnaire assessing patient satisfaction with drug on 3 scales: effectiveness, convenience, and global satisfaction |
| Week 24 and Week 48 |
| Change in Participant-Reported Outcome (PRO) Measures in EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L) Index in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Baseline and Week 24 |
| Change in PRO Measures in EQ-5D-3L Index in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Week 24, Week 48 and Week 72 |
| Change in PRO Measures in EQ-5D-3L Index in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Baseline, Week 24, Week 48 and Week 72 |
| Change in PRO Measures in Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis V2.1 (WPAI: MS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Baseline and Week 24 |
| Change in PRO Measures in WPAI: MS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Week 24, Week 48 and Week 72 |
| Change in PRO Measures in WPAI: MS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Baseline, Week 24, Week 48 and Week 72 |
| Percentage of Participants with Changes in Clinical Status Assessed Using the Expanded Disability Status Scale (EDSS) | The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. | Week 48 |
| Change in PRO Measures in 12-Item Short Form Survey (SF-12) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | A short form survey with 12 questions selected from the SF-36 Health Survey. The questions are weighted and summed to create two scales on physical and mental functioning. Physical Composite Scores (PCS) and Mental Composite Scores (MCS) range from 0 to 100, where a zero indicates the lowest level of health and 100 indicates the highest level of health. | Baseline and Week 24 |
| Change in PRO Measures in SF-12 Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A short form survey with 12 questions selected from the SF-36 Health Survey. The questions are weighted and summed to create two scales on physical and mental functioning. Physical Composite Scores (PCS) and Mental Composite Scores (MCS) range from 0 to 100, where a zero indicates the lowest level of health and 100 indicates the highest level of health. | Week 24, Week 48 and Week 72 |
| Change in PRO Measures in SF-12 Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A short form survey with 12 questions selected from the SF-36 Health Survey. The questions are weighted and summed to create two scales on physical and mental functioning. Physical Composite Scores (PCS) and Mental Composite Scores (MCS) range from 0 to 100, where a zero indicates the lowest level of health and 100 indicates the highest level of health. | Baseline, Week 24, Week 48 and Week 72 |
| Change in PRO Measures in Fatigue Severity Scale (FSS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | A 9-item questionnaire that measures the severity of fatigue and functionality. Each question is scored on a scale of 1 to 7, where 1 equals strongly disagree and 7 equals strongly agree. A higher total score indicates greater fatigue severity and impairment. | Baseline and Week 24 |
| Change in PRO Measures in FSS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A 9-item questionnaire that measures the severity of fatigue and functionality. Each question is scored on a scale of 1 to 7, where 1 equals strongly disagree and 7 equals strongly agree. A higher total score indicates greater fatigue severity and impairment. | Week 24, Week 48 and Week 72 |
| Change in PRO Measures in FSS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A 9-item questionnaire that measures the severity of fatigue and functionality. Each question is scored on a scale of 1 to 7, where 1 equals strongly disagree and 7 equals strongly agree. A higher total score indicates greater fatigue severity and impairment. | Baseline, Week 24, Week 48 and Week 72 |
| Change in PRO Measures in Hospital Anxiety And Depression Scale (HADS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | A 14-item self-rating scale that assesses anxiety and depression. Each question is scored on a scale ranging from 0 to 3. Responses are summed to provide separate scores for anxiety and depression that range from 0 to 21. For each corresponding subscale, a total score of 0-7 equals normal, 8-10 equals borderline case, and 11-21 equals case. | Baseline and Week 24 |
| Change in PRO Measures in HADS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A 14-item self-rating scale that assesses anxiety and depression. Each question is scored on a scale ranging from 0 to 3. Responses are summed to provide separate scores for anxiety and depression that range from 0 to 21. For each corresponding subscale, a total score of 0-7 equals normal, 8-10 equals borderline case, and 11-21 equals case. | Week 24, Week 48 and Week 72 |
| Change in PRO Measures in HADS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A 14-item self-rating scale that assesses anxiety and depression. Each question is scored on a scale ranging from 0 to 3. Responses are summed to provide separate scores for anxiety and depression that range from 0 to 21. For each corresponding subscale, a total score of 0-7 equals normal, 8-10 equals borderline case, and 11-21 equals case. | Baseline, Week 24, Week 48 and Week 72 |
| Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire | A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. | Week 24 and Week 72 |
| Participants Adherence to Study Treatment as Measured by Returned Injection Pens | Treatment adherence surveillance | Week 24 and Week 72 |
| Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. | Baseline, Week 24, Week 48 and Week 72 |
| Participants Adherence to Study Treatment as Measured by Returned Injection Pens in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | Treatment adherence surveillance | Baseline, Week 24, Week 48 and Week 72 |
| Proportion of Pain-Free Participants Immediately After Injection (Defined as 0 mm for All Full-Dose Injections on VAS of Participant-Reported Pain) at End Of the Comparator Period in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | 0 mm for all full-dose injections on Visual Analog Scale (VAS) of participant-reported pain. | Week 24 |
| Proportion of Pain-Free Participants 30 Minutes after Injection (Defined as 0 mm for All Full-Dose Injections on VAS of Participant-Reported Pain) at End of the Comparator Period in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | 0 mm for all full-dose injections on (VAS) of participant-reported pain. | Week 24 |
| Average Change in Participant-Reported VAS Pain Score from Pre-Injection to 30 Minutes Post-Injection in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | Measured by participant-reported VAS pain score | Week 24 |
| Average Change in Participant-Reported VAS Pain Score from Pre-Injection to Immediate Post-Injection in Participants Treated with PLEGRIDY Versus Current SC IFN-Β | Measured by participant-reported VAS pain score | Week 24 |
| Percentage of Participants with Changes in Relapse Activity | Measured by change of ARR pre-study to on-study ARR | Week 72 |
| Annualized Relapse Rate (ARR) in Participants in the Overall Population | Calculated by dividing the total number of participant relapses by the total number of participant years at risk. | Week 72 |
| Proportion of Relapsed Participants in Overall Population | Proportion of total study participants who experienced a confirmed clinical relapse during the study. | Week 72 |
| Percentage of Participants with an Adverse Event (AE), Serious AE, and Discontinuations of Study Treatment due to an AE in Participants Treated with PLEGRIDY Versus Current SC IFN-β | Safety surveillance | Week 24 |
| Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Continuously Treated with PLEGRIDY | Safety surveillance | Week 24, Week 48 and Week 72 |
| Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period | Safety surveillance | Week 24, Week 48 and Week 72 |
| Braga |
| 4710-243 |
| Portugal |
| Centro Hospitalar Cova da Beira | Covilha | 6200-251 | Portugal |
| Hospital Evora | Evora | 7000-811 | Portugal |
| Hospital Dr. Nelio Mendonça | Funchal | 9004-514 | Portugal |
| Hospital da Senhora da Oliveira | Guimarães | 4835-044 | Portugal |
| Centro Hospitalar de Leiria | Leiria | 2410-197 | Portugal |
| Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar Lisboa Norte - Hosp Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Beatriz Ângelo, EPE | Loures | 2674-514 | Portugal |
| ULS Matosinhos | Matosinhos Municipality | 4464-513 | Portugal |
| Hospital Santo Antonio | Porto | 4099-001 | Portugal |
| Hospital de Sao Sebastiao | Santa Maria da Feira | 4520-211 | Portugal |
| Hospital Viana do Castelo | Viana do Castelo | 4904-858 | Portugal |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C428112 | peginterferon beta-1a |
| D000068556 | Interferon beta-1a |
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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