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

NCT03177083 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-11-25

No results posted yet for this study

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

Interventions

DRUG

peginterferon beta-1a

SC every 2 weeks

DRUG

interferon beta-1a

Per Summary of Product Characteristics (SMPC)

DRUG

interferon beta-1b

Per SMPC

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2020-10-26
Completion
2020-10-26

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03177083 on ClinicalTrials.gov