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

June 20, 2018 updated by: Bayer

Cross-sectional Retrospective Study of Therapeutic Compliance 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Four weeks just before baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: At baseline
Age, sex, marital status, education level, employment status
At baseline
Number of patients with MS diagnosis
Time Frame: At baseline
At baseline
Age at first episode and at diagnosis
Time Frame: At baseline
At baseline
Time since last relapse
Time Frame: At baseline
At baseline
Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team
Time Frame: At baseline
At baseline
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.
At baseline
Number of patients with adverse events during the last month
Time Frame: Four weeks just before baseline visit
Four weeks just before baseline visit
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.
At baseline
Time on INFb-1b therapy
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2009

Primary Completion (Actual)

March 30, 2010

Study Completion (Actual)

March 30, 2010

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/01880

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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