Bayer Robust Study

Length of Study 1 year

Real-World Betaseron® Outcomes Study (ROBUST): A twelve-month, US prospective, observational, open-label, single-arm, multi-center outcomes study of Interferon ß-1b (Betaseron®) given every other day for relapsing forms of multiple sclerosis

 

Study objectives

a) To evaluate patient-reported outcomes (PROs) including satisfaction, resource utilization, treatment compliance, and days of work lost during the first year following initiation of Betaseron® therapy, or resumption of Betaseron® therapy after a lag of at least three months.

 

b) To record changes in functional status as measured by the Kurtzke Expanded Disability Status Scale (EDSS) as administered by the patients’ treating neurologists or appropriately trained members of their staffs.

 

c) To collect data on relapses and major resource utilization and on any visits to emergency departments, or urgent care facilities.

 

The study will consist of two major components: 1) a patient questionnaire administered over the Internet, completed at baseline and at monthly intervals for one year thereafter; and 2) neurological examinations reflecting standard of care, administered by the investigators at baseline, six months, and one year. Results of the neurological exams will be reported via electronic case report form (eCRF) and filed via the Internet. In addition, data on patient characteristics and prior treatment will be collected at baseline.

 

Inclusion criteria

Patients must fulfill all the following criteria before being included:

a) Provides written informed consent to participate in the study

b) At least 18 but no more than 65 years old

c) Documented clinical diagnosis of a relapsing form of multiple sclerosis

d) Initiating Betaseron® therapy, or resuming Betaseron® after not having used it for at least three (3) months

e) Willing and able to provide a valid e-mail address which will be in use for the duration of the study

f) Willing and able to complete study questionnaires via the Internet

g) Has reliable Internet access for the duration of the study

h) Completes the baseline MSOQ within 10 days of the initial screening visit

 

Exclusion criteria

Study participants are to be excluded from the study if they display any of the following criteria:

a) Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0

b) 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.

c) Any use of Betaseron® within the three months prior to study entry

d) Inability to read, write, or speak the English language

e) Illness or disease other than multiple sclerosis that the investigator believes is likely to cause the patient’s death or incapacity within twelve months

f) Any severe, uncontrolled illness or condition that the investigator believes could dominate the patient’s quality of life

g) Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon

h) Current use of any immunosuppressive medication

i) Previous participation in a MS clinical trial within the three (3) months prior to study entry

j) Previous use of monoclonal antibodies treating MS within the three (3) months prior to study entry

k) Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations.