CompletedNCT00787657BEACONUpdated Oct 16, 2015

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

An observational study in Relapsing Remitting Multiple Sclerosis (RRMS), sponsored by Bayer. Completed at 36 sites in 36 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-10-16.

Study 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 studied

Relapsing Remitting Multiple Sclerosis (RRMS)

Browse trials for

Keywords

Clinically Isolated Syndrome (CIS)

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 1,723 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: 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

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

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,723 participants (actual)

Groups and cohorts

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

Interventions

DrugInterferon 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

What researchers measure

Primary outcomes

Proportion of patients adhering to treatment
Time frame: 6, 12, 18 and 24 months

Secondary outcomes

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

Study locations

36 sites

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

References and documents

Publications

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. PubMed 34425763 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00787657
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Nov 7, 2008
Start date: Jun 2008
Primary completion: Sep 2013
Completion: Oct 2014
Last update: Oct 16, 2015

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Sclerosis→

Other studies from this sponsor

Bayer

Start the discussion