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

NCT00787657 | Completed

• 3 other identifiers: 13852311941BF0703
• Study Type: observational
• Target: 1,723
• Locations: 35 countries
• Sites: 35

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.

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

Clinically Isolated Syndrome (CIS)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients adhering to treatment

  6, 12, 18 and 24 months

Secondary Outcomes (8)

• Rate of early treatment termination

  6, 12, 18 and 24 months

• Rate of study dropout

  6, 12, 18 and 24 months

• Predictive value of BL parameters, WCQ, HADS, RODQ

  12 and 24 months

• WCQ (Ways of Coping Questionnaire)

  6, 12, 18 and 24 months

• HADS (Hospital Anxiety and Depression Scale)

  6, 12, 18 and 24 months

Study Arms (1)

Arm 1

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

Interventions

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

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

Arm 1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (36)

Unknown Facility

Many Locations, Argentina

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Unknown Facility

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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Unknown Facility

Many Locations, Libya

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Many Locations, Mexico

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Many Locations, Netherlands

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Unknown Facility

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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Unknown Facility

Many Locations, United Arab Emirates

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Unknown Facility

Many Locations, United Kingdom

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Unknown Facility

Many Locations, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 34425763 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

ES (1); DE (1); SL (1); IR (1); NZ (1); TW (1); CA (1); BA (1); LE (1); BE (1); IL (1); AE (1); PA (1); CN (1); CZ (1); JO (1); KR (1); SY (1); LI (1); SE (1); IT (1); CO (1); GB (1); VE (1); SG (1); EG (1); NO (1); AR (1); BO (1); ME (1); FR (1); SA (1); NL (1); PT (1); KU (1)