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Completed

NCT Number: NCT03408093

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Interferon beta-1b (Betaseron, BAY86-5046)

Drug

Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.

Primary outcomes

  1. Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test

    Time frame: Four weeks just before baseline visit

Secondary outcomes

  1. Demographic data

    Time frame: At baseline

    Age, sex, marital status, education level, employment status

  2. Number of patients with MS diagnosis

    Time frame: At baseline

  3. Age at first episode and at diagnosis

    Time frame: At baseline

  4. Time since last relapse

    Time frame: At baseline

  5. Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team

    Time frame: At baseline

  6. Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS

    Time frame: At baseline

    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.

  7. Number of patients with adverse events during the last month

    Time frame: Four weeks just before baseline visit

  8. Clinical setting characteristics like existence of MS unit

    Time frame: At baseline

    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.

  9. Time on INFb-1b therapy

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ADHERENCE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 23, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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