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CompletedNCT02076841SFERAUpdated Jan 27, 2017

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

An observational study in Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS) and Multiple Sclerosis, sponsored by Biogen. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-27.

Sponsored by Biogen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Relapsing-Remitting Multiple Sclerosis
  • Clinical Isolated Syndrome (CIS)
  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Recruitment by participating clinicians in Switzerland and Czech Republic.

Eligibility criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • interferon beta-1a

    30 μg intramuscularly once a week using an injection device (Avonex Pen).

    Device: interferon beta-1a

Interventions

  • Deviceinterferon beta-1a

    Administered as specified in the treatment arm

    Also known as: BG9418, Avonex Pen, Avonex

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What researchers measure

Primary outcomes

  1. Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100

    Time frame: Up to 4 months

Secondary outcomes

  1. Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score

    Time frame: Up to 12 months

  2. Change from baseline in the VAS score of systemic tolerability

    Time frame: Up to 12 months

  3. The percentage of participants still on Avonex Pen

    Time frame: Up to 12 months

  4. 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.

    Time frame: Up to 12 months

  5. The percentage of missed injections

    Time frame: Up to 12 months

  6. 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.

    Time frame: Up to 12 months

07

Study locations

11 sites
  • Research Site
    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
    Bienne, Switzerland
  • Research Site
    Langenthal, Switzerland
  • Research Site
    Lugano, Switzerland
  • Research Site
    Sion, Switzerland
  • Research Site
    Wil, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02076841
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Mar 4, 2014
Start date
Jul 2013
Primary completion
Feb 2016
Completion
Oct 2016
Last update
Jan 27, 2017

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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