A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: SC interferon beta-1aDrug: SC interferon beta-1bDrug: SC Peginterferon beta-1a
- Registration Number
- NCT03347370
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 626
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SC interferon 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). SC interferon beta-1b 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 Peginterferon beta-1a 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).
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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 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.
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.
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 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.
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 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.
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.
Trial Locations
- Locations (1)
Research Site
🇩🇪Göttingen, Germany