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Completed No phase listed Observational

Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron

ClinicalTrials.gov ID: NCT00461396

Public ClinicalTrials.gov record NCT00461396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 4:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

* The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months * Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety. * Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.

Study identification

NCT ID
NCT00461396
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Bayer
Industry
Enrollment
104 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2007 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Nov 2009 (Actual)
Last update posted
Apr 8, 2011

2007 – 2009

United States locations

U.S. sites
19
U.S. states
19
U.S. cities
19
Facility City State ZIP Site status
Not listed Many Locations Alabama — —
Not listed Many Locations Arizona — —
Not listed Many Locations Delaware — —
Not listed Many Locations District of Columbia — —
Not listed Many Locations Florida — —
Not listed Many Locations Georgia — —
Not listed Many Locations Illinois — —
Not listed Many Locations Iowa — —
Not listed Many Locations Louisiana — —
Not listed Many Locations Maine — —
Not listed Many Locations Minnesota — —
Not listed Many Locations Missouri — —
Not listed Many Locations New Jersey — —
Not listed Many Locations New York — —
Not listed Many Locations North Carolina — —
Not listed Many Locations Ohio — —
Not listed Many Locations Pennsylvania — —
Not listed Many Locations Tennessee — —
Not listed Many Locations West Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00461396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 8, 2011 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00461396 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →