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

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ClinicalTrials.gov Identifier: NCT03408093
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaseron, BAY86-5046)

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
Actual Study Start Date : February 3, 2009
Actual Primary Completion Date : March 30, 2010
Actual Study Completion Date : March 30, 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Interferon beta-1b
Patients with CIS, RRMS or SPMS who had more than 6 months in treatment
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408093


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03408093     History of Changes
Other Study ID Numbers: 2008/01880
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Interferon beta-1b (INFb-1b)
Multiple Sclerosis (MS)
Relapsing-remitting MS (RRMS)
Secondary progressive MS (SPMS)
Clinically isolated syndrome (CIS)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic