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

NCT ID: NCT03177083

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-30
• Study Completion Date: 2020-10-26

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).

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

peginterferon beta-1a

Group Type: ACTIVE_COMPARATOR

peginterferon beta-1a

Intervention Type: DRUG

SC every 2 weeks

Current Therapy

Group Type: ACTIVE_COMPARATOR

interferon beta-1a

Intervention Type: DRUG

Per Summary of Product Characteristics (SMPC)

interferon beta-1b

Intervention Type: DRUG

Per SMPC

Interventions

peginterferon beta-1a

SC every 2 weeks

Intervention Type: DRUG

interferon beta-1a

Per Summary of Product Characteristics (SMPC)

Intervention Type: DRUG

interferon beta-1b

Per SMPC

Intervention Type: DRUG

Other Intervention Names

PLEGRIDY, BIIB017; Rebif; Betaferon, Extavia

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Hospital Fernando Fonseca

Amadora, , Portugal

Hospital de Braga

Braga, , Portugal

Centro Hospitalar Cova da Beira

Covilha, , Portugal

Hospital Evora

Evora, , Portugal

Hospital Dr. Nelio Mendonça

Funchal, , Portugal

Hospital da Senhora da Oliveira

Guimarães, , Portugal

Centro Hospitalar de Leiria

Leiria, , Portugal

Hospital Egas Moniz

Lisbon, , Portugal

Hospital da Luz

Lisbon, , Portugal

Centro Hospitalar Lisboa Norte - Hosp Santa Maria

Lisbon, , Portugal

Hospital Beatriz Ângelo, EPE

Loures, , Portugal

ULS Matosinhos

Matosinhos Municipality, , Portugal

Hospital Santo Antonio

Porto, , Portugal

Hospital de Sao Sebastiao

Santa Maria da Feira, , Portugal

Hospital Viana do Castelo

Viana do Castelo, , Portugal

Countries

Portugal

Other Identifiers

2016-000434-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PRT-PEG-15-10880

Identifier Type: -

Identifier Source: org_study_id