Clinical Isolated Syndrome (CIS), Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis
Conditions
Brief 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.
Interventions
DEVICEinterferon beta-1a
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score | Up to 12 months | — |
| The percentage of missed injections | Up to 12 months | — |
| Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score | 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. |
| Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores | 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. |
Countries
Czechia, Switzerland
Outcome results
None listed