Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment (BEACON)

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ClinicalTrials.gov Identifier: NCT00787657

Recruitment Status : Completed

First Posted : November 7, 2008

Last Update Posted : October 16, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Bayer

Study Description

Brief Summary:

The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

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

Study Design

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Study Type :	Observational
Actual Enrollment :	1723 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Betaferon Prospective Study on Adherence, Coping and Nursing Support
Study Start Date :	June 2008
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	October 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon beta Interferon beta-1b

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Arm 1	Drug: Interferon beta-1b (Betaseron, BAY86-5046) Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis

Outcome Measures

Primary Outcome Measures :

Proportion of patients adhering to treatment [ Time Frame: 6, 12, 18 and 24 months ]

Secondary Outcome Measures :

Rate of early treatment termination [ Time Frame: 6, 12, 18 and 24 months ]
Rate of study dropout [ Time Frame: 6, 12, 18 and 24 months ]
Predictive value of BL parameters, WCQ, HADS, RODQ [ Time Frame: 12 and 24 months ]
WCQ (Ways of Coping Questionnaire) [ Time Frame: 6, 12, 18 and 24 months ]
HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 6, 12, 18 and 24 months ]
RODQ (Risk of Dropout Questionnaire) [ Time Frame: Monthly over 6 months; every other month thereafter ]
EDSS (Expanded Disability Status Scale) [ Time Frame: 6, 12, 18 and 24 months ]
Relapse rate [ Time Frame: 6, 12, 18 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis

Criteria

Inclusion Criteria:

Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.

Exclusion Criteria:

Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

Contacts and Locations

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): NCT00787657

Locations

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Argentina

Many Locations, Argentina
Bahrain

Many Locations, Bahrain
Belgium

Many Locations, Belgium
Bosnia and Herzegovina

Many Locations, Bosnia and Herzegovina
Canada

Many Locations, Canada
China

Many Locations, China
Colombia

Many Locations, Colombia
Czech Republic

Many Locations, Czech Republic
Egypt

Many Locations, Egypt
Estonia

Many Locations, Estonia
France

Many Locations, France
Germany

Many Locations, Germany
Iran, Islamic Republic of

Many Locations, Iran, Islamic Republic of
Israel

Many Locations, Israel
Italy

Many Locations, Italy
Jordan

Many Locations, Jordan
Korea, Republic of

Many Locations, Korea, Republic of
Kuwait

Many Locations, Kuwait
Lebanon

Many Locations, Lebanon
Libyan Arab Jamahiriya

Many Locations, Libyan Arab Jamahiriya
Mexico

Many Locations, Mexico
Netherlands

Many Locations, Netherlands
New Zealand

Many Locations, New Zealand
Norway

Many Locations, Norway
Pakistan

Many Locations, Pakistan
Portugal

Many Locations, Portugal
Saudi Arabia

Many Locations, Saudi Arabia
Singapore

Many Locations, Singapore
Slovakia

Many Locations, Slovakia
Slovenia

Many Locations, Slovenia
Sweden

Many Locations, Sweden
Syrian Arab Republic

Many Locations, Syrian Arab Republic
Taiwan

Many Locations, Taiwan
United Arab Emirates

Many Locations, United Arab Emirates
United Kingdom

Many Locations, United Kingdom
Venezuela

Many Locations, Venezuela

Sponsors and Collaborators

Bayer

Investigators

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Study Director:	Bayer Study Director	Bayer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00787657
Other Study ID Numbers:	13852 311941 ( Other Identifier: company internal ) BF0703 ( Other Identifier: company internal )
First Posted:	November 7, 2008 Key Record Dates
Last Update Posted:	October 16, 2015
Last Verified:	October 2015

Keywords provided by Bayer:


Clinically Isolated Syndrome (CIS)

Additional relevant MeSH terms:

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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting 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

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