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

NCT03347370 | Completed

• 1 other identifier: GER-PEG-16-10988
• Study Type: observational
• Target: 626
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

subcutaneous interferon beta therapy multiple sclerosis (MS); injection site reactions (ISR); flu-like symptoms (FLS); non-interventional study (NIS); SC Peginterferon beta-1a; SC interferon beta-1a; SC interferon beta-1b; Plegridy®; Betaferon®; Extavia®; Rebif®

Outcome Measures

Primary Outcomes (2)

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

  ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus.

  Day 1

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

  Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.

  Day 1

Secondary Outcomes (10)

• Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse

  Day 1

• Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician

  Day 1

• Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician

  Day 1

• Duration of ISR (FLS) Reported by Participants, Nurses, and Physician

  Day 1

• Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians

  Day 1

Study Arms (3)

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).

Drug: SC Peginterferon beta-1a

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).

Drug: SC interferon beta-1a

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).

Drug: SC interferon beta-1b

Interventions

SC Peginterferon beta-1a DRUG

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

Also known as: Plegridy

SC Peginterferon beta-1a

SC interferon beta-1a DRUG

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

Also known as: Rebif

SC interferon beta-1a

SC interferon beta-1b DRUG

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

Also known as: Betaferon, Extavia

SC interferon beta-1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with RRMS, who are currently stable on a SC interferon beta treatment for at least three months and maximum four years (switch between SC interferon beta treatments possible) will be enrolled in the study.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead
• AMS Advanced Medical Services GmbH: collaborator

Study Sites (1)

Research Site

Göttingen, 37073, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Injection Site Reaction

Interventions

peginterferon beta-1a; Interferon beta-1a; Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: November 27, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)