Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis

Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01158183

Acronym

ROBUST

Enrollment

226

Registered

2010-07-08

Start date

2007-07-31

Completion date

2009-09-30

Last updated

2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Outcomes, real world and web tool, electronic data capture

Brief summary

A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.

Interventions

DRUGBAY86-5046_Interferon-beta-1b

Electronic questionnaires

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Provides written informed consent to participate in the study * At least 18 but no more than 65 years old * Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS) * Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months * Willing and able to provide a valid e-mail address which will be in use for the duration of the study * Willing and able to complete study questionnaires via the Internet * Has reliable Internet access for the duration of the study * Completes the baseline patient questionnaire

Exclusion criteria

* Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0 * Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire * Any use of Betaseron within the three months prior to study entry * Inability to read, write, or speak the English language * Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months * Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life * Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon * Current use of any immunosuppressive medication * Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry * Previous use of monoclonal antibodies treating MS within the three months prior to study entry * Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations

Design outcomes

Primary

Measure	Time frame
Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients	Baseline, 1 to12 month outcome questionnaires

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026