Relapsing-Remitting Multiple SclerosisSFERANCT02076841
Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen
An observational study of Relapsing-Remitting Multiple Sclerosis and Clinical Isolated Syndrome (CIS), run by Biogen at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS), Multiple Sclerosis
- What is being tested?
- interferon beta-1a
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment by participating clinicians in Switzerland and Czech Republic.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Czechia6 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Jihlava
Research Site
Pilsen
Research Site
Prague
Research Site
Teplice
Switzerland5 sites
Research Site
Biel/Bienne
Research Site
Langenthal
Research Site
Lugano
Research Site
Sion
Research Site
Wil
About this study
Official title: 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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS), Multiple Sclerosis
- Being tested
- interferon beta-1a
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon beta-1aDevice
Also called BG9418, Avonex Pen, Avonex
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| interferon beta-1a | 30 μg intramuscularly once a week using an injection device (Avonex Pen). Receives: Device: interferon beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100
Measured: Up to 4 months
Secondary outcomes (6)
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
Measured: Up to 12 months
Change from baseline in the VAS score of systemic tolerability
Measured: Up to 12 months
The percentage of participants still on Avonex Pen
Measured: 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.
Measured: Up to 12 months
The percentage of missed injections
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076841
- Sponsor's protocol ID
- CHE-AVX-12-10348
- Acronym
- SFERA
- Status last verified
- Jan 2017
- First submitted
- 19 Feb 2014
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
- ClinicalTrials.gov ID
- NCT02076841
- Acronym / sponsor ID
- SFERA / CHE-AVX-12-10348
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS), Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interferon beta-1a | – | Device: interferon beta-1a30 μg intramuscularly once a week using an injection device (Avonex Pen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment by participating clinicians in Switzerland and Czech Republic.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon beta-1aAlso: BG9418, Avonex Pen, AvonexAdministered as specified in the treatment arm | Device | interferon beta-1a |
Primary outcome
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
6 secondary outcomes
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
Time frame: Up to 12 months
Change from baseline in the VAS score of systemic tolerability
Time frame: Up to 12 months
The percentage of participants still on Avonex Pen
Time frame: 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 percentage of missed injections
Time frame: Up to 12 months
Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis and Clinical Isolated Syndrome (CIS), run by Biogen at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.