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

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ClinicalTrials.gov Identifier: NCT03347370
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
AMS Advanced Medical Services GmbH
Information provided by (Responsible Party):
Biogen

November 16, 2017
November 20, 2017
March 22, 2018
November 27, 2017
May 1, 2019   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT03347370 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage of Participants with at Least one ISR (FLS) as Reported by the Phyiscian [ 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Multiple Sclerosis, Relapsing-Remitting
  • Drug: SC 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]).
    Other Name: Plegridy
  • Drug: SC 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]).
    Other Name: Rebif
  • Drug: SC 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.
    Other Names:
    • Betaferon
    • Extavia
  • SC Peginterferon beta-1a
    Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for at least 3 months and maximum 4 years were observed.
    Intervention: Drug: SC Peginterferon beta-1a
  • SC interferon beta-1a
    Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for at least 3 months and maximum 4 years were observed.
    Intervention: Drug: SC interferon beta-1a
  • SC interferon beta-1b
    Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for at least 3 months and maximum 4 years were observed.
    Intervention: Drug: SC interferon beta-1b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
Same as current
August 1, 2019
May 1, 2019   (Final data collection date for primary outcome measure)

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 at least three months but not longer than four years (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Biogen 866-6334636 clinicaltrials@biogen.com
Germany
 
 
NCT03347370
GER-PEG-16-10988
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Biogen
Biogen
AMS Advanced Medical Services GmbH
Study Director: Medical Director Biogen
Biogen
March 2018