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Completed

NCT Number: NCT03347370

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Göttingen, 37073, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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]).

Other names: Plegridy

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]).

Other names: Rebif

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.

Other names: Betaferon, Extavia

Primary outcomes

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Interference Score of ISR (FLS) With Participant's Daily Activities

    Time frame: 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).

  7. Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians

    Time frame: 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.

  8. Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS

    Time frame: 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.

  9. Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy

    Time frame: 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.

  10. Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • AMS Advanced Medical Services GmbH

Registry information

Official study title

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

Acronym: PERFECT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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