NCT01233245

Brief Summary

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,077

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
15 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

5.2 years

First QC Date

October 14, 2010

Last Update Submit

November 14, 2012

Conditions

Relapsing Remitting MS (RRMS)Secondary Progressive MS (SPMS)

Keywords

Multiple SclerosisAdherenceInterferon beta-1bCoping Styles

Outcome Measures

Primary Outcomes (2)

  • Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others.

    After 2 years

  • Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others.

    After 2 years

Secondary Outcomes (4)

  • Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.

    After 2 years

  • Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.

    After 2 years

  • Assessment of coping processes by applying the Ways of Coping Questionnaire.

    After 2 years

  • Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category.

    After 2 years

Study Arms (1)

Group 1

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

Interventions

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

250 µg, sub-cutaneously, on alternate days

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients, who were recruited at neurologic practices or specialized neurological centers, were eligible for selection if they had relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)

You may qualify if:

  • Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
  • Previous treatment with disease modifying drugs
  • Adjustment of disease modifying treatment necessary at the discretion of the investigator

You may not qualify if:

  • Patients not fulfilling the indications in the local prescribing information
  • Refusal to sign inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Iran

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Portugal

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, South Korea

Location

Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, Taiwan

Location

Unknown Facility

Many Locations, Turkey (Türkiye)

Location

Related Publications (1)

  • Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN beta-1b in multiple sclerosis--results of the betaPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

    PMID: 21636099RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2010

First Posted

November 3, 2010

Study Start

April 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

SA(1)TW(1)NL(1)IT(1)KR(1)LE(1)IR(1)PT(1)IL(1)JO(1)CZ(1)TU(1)DE(1)FR(1)ES(1)