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

NCT ID: NCT03347370

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

626 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SC Peginterferon beta-1a

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

SC Peginterferon beta-1a

Intervention Type DRUG

All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).

SC interferon beta-1a

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

SC interferon beta-1a

Intervention Type DRUG

All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).

SC interferon beta-1b

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

SC interferon beta-1b

Intervention Type DRUG

All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.

Interventions

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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 \[SmPC\]).

Intervention Type 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 \[SmPC\]).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Plegridy Rebif Betaferon Extavia

Eligibility Criteria

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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).

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AMS Advanced Medical Services GmbH

INDUSTRY

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Göttingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GER-PEG-16-10988

Identifier Type: -

Identifier Source: org_study_id

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