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

NCT ID: NCT00787657

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1723 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-10-31

Brief Summary

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* 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.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis (RRMS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Argentina

Site Status

Many Locations, , Bahrain

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Many Locations, , Belgium

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Many Locations, , Bosnia and Herzegovina

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Many Locations, , Canada

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Many Locations, , China

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Many Locations, , Colombia

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Many Locations, , Czechia

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Many Locations, , Egypt

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Many Locations, , Estonia

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Many Locations, , France

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Many Locations, , Germany

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Many Locations, , Iran

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Many Locations, , Israel

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Many Locations, , Italy

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Many Locations, , Jordan

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Many Locations, , Kuwait

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Many Locations, , Lebanon

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Many Locations, , Libya

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Many Locations, , Mexico

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Many Locations, , Netherlands

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Many Locations, , New Zealand

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Many Locations, , Norway

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Many Locations, , Pakistan

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Many Locations, , Portugal

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Many Locations, , Saudi Arabia

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Many Locations, , Singapore

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Many Locations, , Slovakia

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Many Locations, , Slovenia

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Many Locations, , South Korea

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Many Locations, , Sweden

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Many Locations, , Syria

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Many Locations, , Taiwan

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Many Locations, , United Arab Emirates

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Many Locations, , United Kingdom

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Many Locations, , Venezuela

Site Status

Countries

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Argentina Bahrain Belgium Bosnia and Herzegovina Canada China Colombia Czechia Egypt Estonia France Germany Iran Israel Italy Jordan Kuwait Lebanon Libya Mexico Netherlands New Zealand Norway Pakistan Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Sweden Syria Taiwan United Arab Emirates United Kingdom Venezuela

References

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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.

Reference Type DERIVED
PMID: 34425763 (View on PubMed)

Other Identifiers

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311941

Identifier Type: OTHER

Identifier Source: secondary_id

BF0703

Identifier Type: OTHER

Identifier Source: secondary_id

13852

Identifier Type: -

Identifier Source: org_study_id

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