Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

Multiple Sclerosis Clinical Trial

— ADHERENCE  

Official title:

Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408093
• Other study ID #: 2008/01880
• Status: Completed
• Start date: February 3, 2009
• Est. completion date: March 30, 2010

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2010
• Est. primary completion date: March 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b

Exclusion Criteria:

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

References & Publications (1)

Fernández O, Agüera E, Izquierdo G, Millán-Pascual J, Ramió I Torrentà L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farrés J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon ß-1b treatment in patients with multiple scler — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test		Four weeks just before baseline visit
Secondary	Demographic data	Age, sex, marital status, education level, employment status	At baseline
Secondary	Number of patients with MS diagnosis		At baseline
Secondary	Age at first episode and at diagnosis		At baseline
Secondary	Time since last relapse		At baseline
Secondary	Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team		At baseline
Secondary	Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS	The EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis.	At baseline
Secondary	Number of patients with adverse events during the last month		Four weeks just before baseline visit
Secondary	Clinical setting characteristics like existence of MS unit	The existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department.	At baseline
Secondary	Time on INFb-1b therapy		At baseline

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