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

Biogen

Status and phase

Completed

Phase 4

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: peginterferon beta-1a

Drug: interferon beta-1a

Drug: interferon beta-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT03177083

PRT-PEG-15-10880

2016-000434-21 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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