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

Relapsing Remitting Multiple Sclerosis (RRMS) Clinical Trial

— BEACON  

Official title:

Betaferon Prospective Study on Adherence, Coping and Nursing Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787657
• Other study ID #: 13852
• Secondary ID: 311941BF0703
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: October 15, 2015
• Start date: June 2008
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeCanada: Ethics Review CommitteeFrance: Institutional Ethical CommitteeIsrael: Ethics CommissionItaly: Ethics CommitteeNew Zealand: Institutional Review BoardPortugal: Health Ethic CommitteeSingapore: Domain Specific Review BoardsSlovakia: State Institute for Drug ControlSouth Korea: Institutional Review BoardTaiwan: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeColombia: Ethics CommitteeColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosSweden: Ethics CommitteeVenezuela: Ethic Commitees & Instituto Nacional de HigieneNorway: Ethics CommitteeSlovenia: National Medical Ethics Committee of the Republic of SloveniaJordan: Ethical CommitteeLebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1723
• Est. completion date: October 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Bahrain,  Belgium,  Bosnia and Herzegovina,  Canada,  China,  Colombia,  Czech Republic,  Egypt,  Estonia,  France,  Germany,  Iran, Islamic Republic of,  Israel,  Italy,  Jordan,  Korea, Republic of,  Kuwait,  Lebanon,  Libyan Arab Jamahiriya,  Mexico,  Netherlands,  New Zealand,  Norway,  Pakistan,  Portugal,  Saudi Arabia,  Singapore,  Slovakia,  Slovenia,  Sweden,  Syrian Arab Republic,  Taiwan,  United Arab Emirates,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients adhering to treatment		6, 12, 18 and 24 months	No
Secondary	Rate of early treatment termination		6, 12, 18 and 24 months	No
Secondary	Rate of study dropout		6, 12, 18 and 24 months	No
Secondary	Predictive value of BL parameters, WCQ, HADS, RODQ		12 and 24 months	No
Secondary	WCQ (Ways of Coping Questionnaire)		6, 12, 18 and 24 months	No
Secondary	HADS (Hospital Anxiety and Depression Scale)		6, 12, 18 and 24 months	No
Secondary	RODQ (Risk of Dropout Questionnaire)		Monthly over 6 months; every other month thereafter	No
Secondary	EDSS (Expanded Disability Status Scale)		6, 12, 18 and 24 months	No
Secondary	Relapse rate		6, 12, 18 and 24 months	No

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