Relapsing Remitting Multiple SclerosisPhase 4PLENONCT03177083
Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
A Phase 4 study testing peginterferon beta-1a, interferon beta-1a and interferon beta-1b in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 15 sites in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- peginterferon beta-1a, interferon beta-1a and interferon beta-1b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 15 sitesPortugal
- Study dates
- 30 Jan 2017to 26 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of RRMS, as defined by McDonald criteria (2017).
- An EDSS score between 0 and 5.0.
- All female participants 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.
- On continual treatment for ≥6 months with a single current SC IFN-β therapy, including IFN-β-1b 0.25 mg SC every other day or IFN-β-1a 22 μg or 44 μg SC 3 times weekly
Who cannot join
- Known history of human immunodeficiency virus.
- Known history of or positive test result for antibodies to hepatitis C, or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb]) at Screening. Participants with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb], and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel [CDC 2007]).
- An MS relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization (Day 1).
- Any previous treatment with PLEGRIDY.
- NOTE: Other protocol defined Inclusion/Exclusion may apply
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Portugal15 sites
Hospital Fernando Fonseca
Amadora, 2720-276
Hospital de Braga
Braga, 4710-243
Centro Hospitalar Cova da Beira
Covilha, 6200-251
Hospital Evora
Evora, 7000-811
Hospital Dr. Nelio Mendonça
Funchal, 9004-514
Hospital da Senhora da Oliveira
Guimarães, 4835-044
Centro Hospitalar de Leiria
Leiria, 2410-197
Hospital Egas Moniz
Lisbon, 1349-019
Hospital da Luz
Lisbon, 1500-650
Centro Hospitalar Lisboa Norte - Hosp Santa Maria
Lisbon, 1649-035
Hospital Beatriz Ângelo, EPE
Loures, 2674-514
ULS Matosinhos
Matosinhos Municipality, 4464-513
Hospital Santo Antonio
Porto, 4099-001
Hospital de Sao Sebastiao
Santa Maria da Feira, 4520-211
Hospital Viana do Castelo
Viana do Castelo, 4904-858
About this study
Official title: Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)
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).
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- peginterferon beta-1a, interferon beta-1a, interferon beta-1b
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon beta-1aDrug
Also called PLEGRIDY, BIIB017
SC every 2 weeks
interferon beta-1aDrug
Also called Rebif
Per Summary of Product Characteristics (SMPC)
interferon beta-1bDrug
Also called Betaferon, Extavia
Per SMPC
| Study group | Role | What they receive |
|---|---|---|
| peginterferon beta-1a | Active comparator | Not described Receives: Drug: peginterferon beta-1a |
| Current Therapy | Active comparator | Not described Receives: Drug: interferon beta-1a; Drug: interferon beta-1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS)
FLS as defined by chills, pyrexia, myalgia, and asthenia
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Week 24
Secondary outcomes (32)
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
Measured: Baseline to Week 24
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24 and Week 72
Participants Adherence to Study Treatment as Measured by Returned Injection Pens
Treatment adherence surveillance
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Week 24
Percentage of Participants with Changes in Relapse Activity
Measured by change of ARR pre-study to on-study ARR
Measured: 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.
Measured: Week 72
Proportion of Relapsed Participants in Overall Population
Proportion of total study participants who experienced a confirmed clinical relapse during the study.
Measured: 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
Measured: 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
Measured: 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
Measured: Week 24, Week 48 and Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start30 Jan 2017
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177083
- Sponsor's protocol ID
- PRT-PEG-15-10880
- Other IDs
- 2016-000434-21, 2016
- Acronym
- PLENO
- Status last verified
- Nov 2020
- First submitted
- 26 Jan 2017
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)
- ClinicalTrials.gov ID
- NCT03177083
- Acronym / sponsor ID
- PLENO / PRT-PEG-15-10880
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peginterferon beta-1a | Active comparator | Drug: peginterferon beta-1a |
| Current Therapy | Active comparator | Drug: interferon beta-1a, Drug: interferon beta-1b |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A confirmed diagnosis of RRMS, as defined by McDonald criteria (2017).
- An EDSS score between 0 and 5.0.
- All female participants 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.
- On continual treatment for ≥6 months with a single current SC IFN-β therapy, including IFN-β-1b 0.25 mg SC every other day or IFN-β-1a 22 μg or 44 μg SC 3 times weekly
Key exclusion criteria (5 listed)
- Known history of human immunodeficiency virus.
- Known history of or positive test result for antibodies to hepatitis C, or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb]) at Screening. Participants with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb], and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel [CDC 2007]).
- An MS relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization (Day 1).
- Any previous treatment with PLEGRIDY.
- NOTE: Other protocol defined Inclusion/Exclusion may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon beta-1aAlso: PLEGRIDY, BIIB017SC every 2 weeks | Drug | peginterferon beta-1a |
| interferon beta-1aAlso: RebifPer Summary of Product Characteristics (SMPC) | Drug | Current Therapy |
| interferon beta-1bAlso: Betaferon, ExtaviaPer SMPC | Drug | Current Therapy |
Primary outcome
Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS)
Time frame: Up to Week 24
FLS as defined by chills, pyrexia, myalgia, and asthenia
Combined Counts of AEs of Injection Site Reactions (ISRs)
Time frame: Up to Week 24
Defined as a post-application assessment score ≥2 in participant assessments using the Patient's Erythema Self-Assessment 1 (PSA) scale
Combined Counts of AEs of Injection Site Reactions (ISRs)
Time frame: Up to Week 24
Defined as a post-application assessment score ≥2 in clinician assessments using the Clinician Erythema Assessment (CEA) scale
Combined Counts of AEs of ISR Pain (ISRP)
Time frame: Up to Week 24
Defined as visual analog scale (VAS) associated with ISR ≥1 immediately after injection or 30 minutes post-injection
32 secondary outcomes
Change in Participant-Reported Treatment Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) in Participants Treated with PLEGRIDY Versus Current SC IFN-β
Time frame: Baseline to Week 24
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 24, Week 48 and Week 72
Percentage of Participants with Changes in Clinical Status Assessed Using the Expanded Disability Status Scale (EDSS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 24, Week 48 and Week 72
Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire
Time frame: Week 24 and Week 72
Participants Adherence to Study Treatment as Measured by Returned Injection Pens
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 24
Percentage of Participants with Changes in Relapse Activity
Time frame: Week 72
Annualized Relapse Rate (ARR) in Participants in the Overall Population
Time frame: Week 72
Proportion of Relapsed Participants in Overall Population
Time frame: 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
Time frame: Week 24
Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Continuously Treated with PLEGRIDY
Time frame: 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
Time frame: Week 24, Week 48 and Week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peginterferon beta-1a, interferon beta-1a and interferon beta-1b in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 15 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS) (time frame: Up to Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.