MSFrontier

PLENO

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™)
CompletedPhase 4Relapsing MSNCT031770832016-000434-21

What it found

No result found

We found no results in the registry or in papers.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS)

    Up to Week 24

    Safety

  • Combined Counts of AEs of Injection Site Reactions (ISRs)

    Up to Week 24

    Safety

  • Combined Counts of AEs of ISR Pain (ISRP)

    Up to Week 24

    Pain

  • The primary endpoint that relates to this objective is the combined counts of AEs of FLS (chills, pyrexia, myalgia, and asthenia), ISRs (defined as a post-application assessment score ≥2 in subject and clinician assessments using the PSA and CEA scales respectively), and ISR P (defined as VAS associated with ISR ≥1 immediately after injection or 30 minutes post-injection) over the first 24 weeks o

Other measures (33)

  • Change in Participant-Reported Treatment Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) in Participants Treated with PLEGRIDY Versus Current SC IFN-β

    Baseline to Week 24

    Quality of life (reported by participants)

  • 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

    Week 24 and Week 48

    Quality of life (reported by participants)

  • 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

    Baseline and Week 24

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • 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

    Week 24, Week 48 and Week 72

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • 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

    Baseline, Week 24, Week 48 and Week 72

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • 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

    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

    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

    Baseline, Week 24, Week 48 and Week 72

  • Percentage of Participants with Changes in Clinical Status Assessed Using the Expanded Disability Status Scale (EDSS)

    Week 48

    Disability progression

  • Change in PRO Measures in 12-Item Short Form Survey (SF-12) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β

    Baseline and Week 24

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * 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: * 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Jan 2017

    2. Main results due

      Oct 2020

    3. Finished

      Oct 2020

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