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

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Bayer

Status

Completed

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: BAY86-5046_Interferon-beta-1b

Study type

Observational

Funder types

Industry

Identifiers

NCT01158183
14838
311644
BF0714US

Details and patient eligibility

About

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.

Enrollment

226 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

226 participants in 1 patient group

Group 1
Description:
No intervention
Treatment:
Drug: BAY86-5046_Interferon-beta-1b

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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