Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen (SFERA)

Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)

To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Clinical Isolated Syndrome (CIS)
• Intervention / Treatment: Device: interferon beta-1a

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic
    • Research Site
  • Hradec Králové, Czech Republic
    • Research Site
  • Jihlava, Czech Republic
    • Research Site
  • Plzeň, Czech Republic
    • Research Site
  • Praha, Czech Republic
    • Research Site
  • Teplice, Czech Republic
    • Research Site
• Switzerland
  • Bienne, Switzerland
    • Research Site
  • Langenthal, Switzerland
    • Research Site
  • Lugano, Switzerland
    • Research Site
  • Sion, Switzerland
    • Research Site
  • Wil, Switzerland
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Recruitment by participating clinicians in Switzerland and Czech Republic.

Description

Key Inclusion Criteria:

• Continuous treatment with Rebif, Betaferon or Copaxone over at least the past year.
• Injections site tolerability issues documented in medical records or by a nurse at inclusion.
• Clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on therapy.
• Documented neurological history at least for the year prior to study entry.
• Qualification for Avonex® (Avonex Pen) according to the approved indication (Clinical Isolated Syndrome) or Relapsing Remitting Multiple Sclerosis (RRMS).
• Acceptance of magnetic resonance imaging.

Key Exclusion Criteria:

• Patients who have previously entered this study.
• Treatment with Avonex during the 12 months prior to the study.
• One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study.
• Patient on Betaferon with Neutralizing Antibodies (NAbs) more than 400 TRU (tenfold reduction units) and patients on Rebif with NAbs with more than 100 TRU.
• Secondary progressive multiple sclerosis.
• Primary progressive multiple sclerosis.
• Pregnancy or breast feeding.
• History of severe depression or attempted suicide or current suicidal ideation.
• Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study.
• Uncontrolled seizure disorder.
• Myopathy or clinically significant liver disease.
• Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study.
• Known hypersensitivity to interferon-beta or other human proteins including albumin.
• A history of drug abuse in the 6 months prior to screening.
• Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
• Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
interferon beta-1a; 30 μg intramuscularly once a week using an injection device (Avonex Pen).	Device: interferon beta-1a; Administered as specified in the treatment arm; Other Names: Avonex; BG9418; Avonex Pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score		Up to 12 months
Change from baseline in the VAS score of systemic tolerability		Up to 12 months
The percentage of participants still on Avonex Pen		Up to 12 months
Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores	The SF-36 is a short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.	Up to 12 months
The percentage of missed injections		Up to 12 months
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score	Fatigue is rated using the self-administered FSMC questionnaire that includes ten questions that relate to motor fatigue and ten to cognitive fatigue. Higher scores indicate higher fatigue.	Up to 12 months

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: CHE-AVX-12-10348