ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03347370
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
AMS Advanced Medical Services GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Drug: SC Peginterferon beta-1a Drug: SC interferon beta-1a Drug: SC interferon beta-1b

Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : August 1, 2019


Group/Cohort Intervention/treatment
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).
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

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).
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

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).
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347370


Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
Germany
Research Site Recruiting
Göttingen, Germany, 37073
Sponsors and Collaborators
Biogen
AMS Advanced Medical Services GmbH
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03347370     History of Changes
Other Study ID Numbers: GER-PEG-16-10988
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
flu-like symptoms (FLS)
subcutaneous interferon beta therapy multiple sclerosis (MS)
injection site reactions (ISR)
non-interventional study (NIS)
SC Peginterferon beta-1a
SC interferon beta-1a
SC interferon beta-1b
Plegridy®
Betaferon®
Extavia®
Rebif®

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic