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

January 26, 2017 updated by: Biogen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Up to 4 months
Up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
Time Frame: Up to 12 months
Up to 12 months
Change from baseline in the VAS score of systemic tolerability
Time Frame: Up to 12 months
Up to 12 months
The percentage of participants still on Avonex Pen
Time Frame: Up to 12 months
Up to 12 months
Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
Up to 12 months
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score
Time Frame: Up to 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHE-AVX-12-10348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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