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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347370
Other study ID # GER-PEG-16-10988
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 27, 2017
Est. completion date July 31, 2019

Study information

Verified date September 2019
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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]).
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]).
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.

Locations

Country Name City State
Germany Research Site Göttingen

Sponsors (2)

Lead Sponsor Collaborator
Biogen AMS Advanced Medical Services GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Day 1
Primary Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness. Day 1
Secondary Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse 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. Day 1
Secondary Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician 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. Day 1
Secondary Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician 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. Day 1
Secondary Duration of ISR (FLS) Reported by Participants, Nurses, and Physician 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. Day 1
Secondary Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians 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. Day 1
Secondary Interference Score of ISR (FLS) With Participant's Daily Activities 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). Day 1
Secondary Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians 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. Day 1
Secondary Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS 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. Day 1
Secondary Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy 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. Day 1
Secondary Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy 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. Day 1
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