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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02076841
• Date of registration: 19/02/2014
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen SFERA
• Scientific title: Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
• Date of first enrolment: July 2013
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02076841
• Study type: Observational
• Phase: N/A

Countries of recruitment

Czech Republic, Switzerland

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Clinical Isolated Syndrome (CIS)

Intervention(s)

Device: interferon beta-1a

Primary Outcome(s)

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 Outcome(s)

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 participants still on Avonex Pen [Time Frame: Up to 12 months]

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]

Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score [Time Frame: Up to 12 months]

The percentage of missed injections [Time Frame: Up to 12 months]

Secondary ID(s)

CHE-AVX-12-10348

Source(s) of Monetary Support

Please refer to primary and secondary sponsors