Clinical trial NCT02076841: Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen
Official title: Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Clinical Isolated Syndrome (CIS)
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment by participating clinicians in Switzerland and Czech Republic.

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.


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.

Primary outcomes:
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
timeFrame: Up to 4 months
Secondary outcomes:
measure: Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
timeFrame: Up to 12 months
measure: Change from baseline in the VAS score of systemic tolerability
timeFrame: Up to 12 months
measure: The percentage of participants still on Avonex Pen
timeFrame: Up to 12 months
measure: Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores
timeFrame: Up to 12 months
measure: The percentage of missed injections
timeFrame: Up to 12 months
measure: Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Králové
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Plzeň
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Teplice
country: Czech Republic
facility: Research Site
city: Bienne
country: Switzerland
facility: Research Site
city: Langenthal
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
city: Wil
country: Switzerland
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: