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

Study Overview
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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.

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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: SC Peginterferon beta-1a
* Drug: SC interferon beta-1a
* Drug: SC interferon beta-1b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SC Peginterferon beta-1a<br>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<br>* All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).<br>* Other names: Plegridy;|
| SC interferon beta-1a<br>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<br>* All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).<br>* Other names: Rebif;|
| SC interferon beta-1b<br>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<br>* All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.<br>* Other names: Extavia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Duration of ISR (FLS) Reported by Participants, Nurses, and Physician | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Interference Score of ISR (FLS) With Participant's Daily Activities | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. Interference of ISR (FLS) with participant's daily activities will be assessed by a visual analogue scale ranging from '0' (not at all) to '10' (extremely). | Day 1 | 
| Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 
| Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy | ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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®