NCT03177083

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 microgram (μg) subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_4

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

January 26, 2017

Last Update Submit

November 23, 2020

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • 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

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

    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

    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

    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

    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

    Baseline, Week 24, Week 48 and Week 72

  • +27 more secondary outcomes

Study Arms (2)

peginterferon beta-1a

ACTIVE COMPARATOR
Drug: peginterferon beta-1a

Current Therapy

ACTIVE COMPARATOR
Drug: interferon beta-1aDrug: interferon beta-1b

Interventions

peginterferon beta-1aDRUG

SC every 2 weeks

Also known as: PLEGRIDY, BIIB017
peginterferon beta-1a
interferon beta-1aDRUG

Per Summary of Product Characteristics (SMPC)

Also known as: Rebif
Current Therapy
interferon beta-1bDRUG

Per SMPC

Also known as: Betaferon, Extavia
Current Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Fernando Fonseca

Amadora, 2720-276, Portugal

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar Cova da Beira

Covilha, 6200-251, Portugal

Location

Hospital Evora

Evora, 7000-811, Portugal

Location

Hospital Dr. Nelio Mendonça

Funchal, 9004-514, Portugal

Location

Hospital da Senhora da Oliveira

Guimarães, 4835-044, Portugal

Location

Centro Hospitalar de Leiria

Leiria, 2410-197, Portugal

Location

Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar Lisboa Norte - Hosp Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Beatriz Ângelo, EPE

Loures, 2674-514, Portugal

Location

ULS Matosinhos

Matosinhos Municipality, 4464-513, Portugal

Location

Hospital Santo Antonio

Porto, 4099-001, Portugal

Location

Hospital de Sao Sebastiao

Santa Maria da Feira, 4520-211, Portugal

Location

Hospital Viana do Castelo

Viana do Castelo, 4904-858, Portugal

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

peginterferon beta-1aInterferon beta-1aInterferon beta-1b

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

June 6, 2017

Study Start

January 30, 2017

Primary Completion

October 26, 2020

Study Completion

October 26, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

PT(15)