Clinical trial NCT01158183: Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Outcomes
real world and web tool
electronic data capture
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "real world" population

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, 1 to12 month outcome questionnaires
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: United States
state: Alabama
city: Many Locations
country: United States
state: California
city: Many Locations
country: United States
state: Colorado
city: Many Locations
country: United States
state: Florida
city: Many Locations
country: United States
state: Illinois
city: Many Locations
country: United States
state: Iowa
city: Many Locations
country: United States
state: Kansas
city: Many Locations
country: United States
state: Louisiana
city: Many Locations
country: United States
state: Maine
city: Many Locations
country: United States
state: Massachusetts
city: Many Locations
country: United States
state: Michigan
city: Many Locations
country: United States
state: Missouri
city: Many Locations
country: United States
state: Nevada
city: Many Locations
country: United States
state: New Hampshire
city: Many Locations
country: United States
state: New Jersey
city: Many Locations
country: United States
state: New York
city: Many Locations
country: United States
state: North Carolina
city: Many Locations
country: United States
state: North Dakota
city: Many Locations
country: United States
state: Ohio
city: Many Locations
country: United States
state: Oregon
city: Many Locations
country: United States
state: Pennsylvania
city: Many Locations
country: United States
state: Rhode Island
city: Many Locations
country: United States
state: Tennessee
city: Many Locations
country: United States
state: Texas
city: Many Locations
country: United States
state: Virginia
city: Many Locations
country: United States
state: Washington
city: Many Locations
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: