NCT03177083

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

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™)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	peginterferon beta-1a	SC every 2 weeks
DRUG	interferon beta-1a	Per Summary of Product Characteristics (SMPC)
DRUG	interferon beta-1b	Per SMPC

Timeline

• Start date: 2017-01-30
• Primary completion: 2020-10-26
• Completion: 2020-10-26
• First posted: 2017-06-06
• Last updated: 2020-11-25

Locations

15 sites across 1 country: Portugal