Multiple Sclerosis, Relapsing-Remitting
Conditions
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®
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.
Interventions
DRUGSC 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 \[SmPC\]).
DRUGSC 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 \[SmPC\]).
DRUGSC 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.
Sponsors
AMS Advanced Medical Services GmbH
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants | Day 1 | ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. |
| Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants | Day 1 | Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician | Day 1 | 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. |
| Duration of ISR (FLS) Reported by Participants, Nurses, and Physician | Day 1 | 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. |
| Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians | Day 1 | 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. |
| Interference Score of ISR (FLS) With Participant's Daily Activities | Day 1 | 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). |
| Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse | Day 1 | 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. |
| Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS | Day 1 | 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. |
| Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy | Day 1 | 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. |
| Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy | Day 1 | 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. |
| Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians | Day 1 | 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. |
| Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician | Day 1 | 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. |
Countries
Germany
Outcome results
None listed