CompletedNot Applicable

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

Germany626 participantsStarted 2017-11-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Ability to understand the purpose of the study and provide signed and dated informed consent * Diagnosed relapsing-remitting multiple sclerosis * Currently receiving a SC interferon beta treatment (label conform) * Stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible). Key Exclusion Criteria: * Contraindications according to the Fachinformation (German equivalent to Summary of Product Characteristics \[SmPC\]) * Treatment with Glatiramer acetate and intramuscular (IM) interferon beta-1a * Participation in a non-interventional or interventional clinical study of Biogen

What they're measuring

Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants

Timeframe: Day 1

Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants

Timeframe: Day 1

Trial details

NCT IDNCT03347370

SponsorBiogen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing-Remitting trials