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Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy (PLENO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03177083
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 comparator period) with PLEGRIDY 125 μg subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: peginterferon beta-1a Drug: interferon beta-1a Drug: interferon beta-1b Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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™)
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: peginterferon beta-1a Drug: peginterferon beta-1a
SC every 2 weeks
Other Name: PLEGRIDY, BIIB017
Active Comparator: Current Therapy Drug: interferon beta-1a
Per Summary of Product Characteristics (SMPC)
Other Name: Rebif
Drug: interferon beta-1b
Per SMPC
Other Name: Betaferon, Extavia


Outcome Measures

Primary Outcome Measures :
  1. Combined counts of Adverse Events (AEs) of flu-like symptoms (FLS) [ Time Frame: Up to week 80 ]
    FLS as defined by chills, pyrexia, myalgia, and asthenia

  2. Combined counts of AEs of injection site reactions (ISRs) [ Time Frame: Up to week 80 ]
    Defined as a post-application assessment score ≥2 in participant assessments using the Patient's Erythema Self-Assessment 1 (PSA) scale

  3. Combined counts of AEs of injection site reactions (ISRs) [ Time Frame: Up to week 80 ]
    Defined as a post-application assessment score ≥2 in clinician assessments using the Clinician Erythema Assessment (CEA) scale

  4. Combined counts of AEs of ISR pain (ISRP) [ Time Frame: Up to week 80 ]
    Defined as visual analog scale (VAS) associated with ISR ≥1 immediately after injection or 30 minutes post-injection


Secondary Outcome Measures :
  1. Treatment SatisfactiQuestionnaire for Medication (TSQM-9) [ Time Frame: Up to week 80 ]
    A questionnaire assessing patient satisfaction with drug on 3 scales: effectiveness, convenience, and global satisfaction

  2. Change in participant-reported treatment satisfaction using TSQM-9 in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline to week 24 ]
    A questionnaire assessing patient satisfaction with drug on 3 scales: effectiveness, convenience, and global satisfaction

  3. 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 ]
    A questionnaire assessing patient satisfaction with drug on 3 scales: effectiveness, convenience, and global satisfaction

  4. EuroQoL EQ-5D, 3level (EQ-5D-3L) [ Time Frame: Up to week 80 ]
    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.

  5. Change in (PRO) measures in EQ-5D-3L index in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline and week 24 ]
    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.

  6. 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 80 ]
    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.

  7. 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 80 ]
    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.

  8. Work Productivity and Activity Impairment - Multiple Sclerosis Questionnaire (WPAI: MS) [ Time Frame: Up to week 80 ]
    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.

  9. Change in PRO measures in WPAI: MS score in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline and week 24 ]
    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.

  10. 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 80 ]
    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.

  11. 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 80 ]
    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.

  12. Expanded Disability Status Scale (EDSS) [ Time Frame: Up to week 80 ]
    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.

  13. Percentage of participants with changes in Clinical Status assessed using the (EDSS) [ Time Frame: Week 48 ]
    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.

  14. Short-Form 12 scores (SF-12) [ Time Frame: Up to week 80 ]
    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.

  15. Change in patient-reported outcome (PRO) measures in SF-12 score in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline and week 24 ]
    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.

  16. 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 80 ]
    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.

  17. 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 80 ]
    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.

  18. Fatigue Severity Scale (FSS) [ Time Frame: Up to week 80 ]
    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.

  19. Change in (PRO) measures in FSS score in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline and week 24 ]
    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.

  20. 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 80 ]
    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.

  21. 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 80 ]
    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.

  22. Hospital Anxiety and Depression Scale Questionnaire (HADS) [ Time Frame: Up to week 80 ]
    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.

  23. Change in (PRO) measures in HADS score in participants treated with PLEGRIDY versus current SC IFN-β [ Time Frame: Baseline and week 24 ]
    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.

  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 80 ]
    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.

  25. 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 80 ]
    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.

  26. Treatment adherence questionnaire [ Time Frame: Up to 80 weeks ]
    A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.

  27. Participants adherence to study treatment as measured by treatment adherence questionnaire [ Time Frame: Week 24, Week 80 ]
    A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.

  28. Participants adherence to study treatment as measured by returned injection pens [ Time Frame: Week 24, Week 80 ]
    Treatment adherence surveillance

  29. 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, week 80 ]
    A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.

  30. 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, week 80 ]
    Treatment adherence surveillance

  31. 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 ]
    0 mm for all full-dose injections on Visual Analog Scale (VAS) of participant-reported pain.

  32. 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 ]
    0 mm for all full-dose injections on (VAS) of participant-reported pain.

  33. 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 ]
    Measured by participant-reported VAS pain score

  34. 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 ]
    Measured by participant-reported VAS pain score

  35. Percentage of participants with changes Relapse activity [ Time Frame: Week 80 ]
    Measured by change of ARR pre-study to on-study ARR

  36. ARR in participants in the overall population [ Time Frame: Week 80 ]
    Calculated by dividing the total number of participant relapses by the total number of participant years at risk.

  37. Proportion of relapsed participants in overall population [ Time Frame: Week 80 ]
    Proportion of total study participants who experienced a confirmed clinical relapse during the study.

  38. 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 ]
    Safety surveillance

  39. 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 80 ]
    Safety surveillance

  40. 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 80 ]
    Safety surveillance


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • A confirmed diagnosis of RRMS, as defined by McDonald criteria (Polman 2011).
  • 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 g or 44 μg SC 3 times weekly

Key Exclusion Criteria:

  • 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177083


Contacts
Contact: US Biogen Medical Information 866-633-4636 clinicaltrials@biogen.com

Locations
Portugal
Hospital Fernando Fonseca Recruiting
Amadora, Portugal, 2720-276
Principal Investigator: Antonio Salgado, MD         
Hospital de Braga Recruiting
Braga, Portugal, 4710-243
Principal Investigator: Cerqueira Joao, MD         
Hospital Evora Recruiting
Evora, Portugal, 7000-811
Principal Investigator: Dulce Neutel, MD         
Hospital Gaia e Espinho Active, not recruiting
Gaia, Portugal, 4400-129
Hospital da Senhora da Oliveira Recruiting
Guimaraes, Portugal, 4835-044
Principal Investigator: Angela Silva, MD         
Hospital Dos Capuchos Active, not recruiting
Lisboa, Portugal, 1169-050
Hospital Egas Moniz Recruiting
Lisboa, Portugal, 1349-019
Principal Investigator: Francisca Sa, MD         
Hospital da Luz Recruiting
Lisboa, Portugal, 1500-650
Principal Investigator: Ines Marques, MD         
ULS Matosinhos Recruiting
Matosinhos, Portugal, 4464-513
Principal Investigator: Filipe Correia, MD         
Hospital Santo Antonio Recruiting
Porto, Portugal, 4099-001
Principal Investigator: Ana Silva, MD         
Hospital de Sao Sebastiao Recruiting
Santa Maria da Feira, Portugal, 4520-211
Principal Investigator: Loureiro, MD         
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03177083     History of Changes
Other Study ID Numbers: PRT-PEG-15-10880
2016-000434-21 ( EudraCT Number )
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic