NCT03347370

A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis

Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 626 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported by the relapsing-remitting multiple sclerosis (RRMS) participants.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	SC Peginterferon beta-1a	All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).
DRUG	SC interferon beta-1a	All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).
DRUG	SC interferon beta-1b	All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.

Timeline

• Start date: 2017-11-27
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2017-11-20
• Last updated: 2019-09-25

Locations

1 site across 1 country: Germany