Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10071068 Term: Clinically isolated syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Bayer AG,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study. Also, those original BENEFIT subjects who prematurely discontinued study participation in any of the prior BENEFIT studies areeligible for inclusion in the BENEFIT 15 study. 2.Subjects with signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Subjects who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the subject’s ability to understand the purpose of the study 2.Subjects who meet any of the following criteria will only be excluded from the MRI assessment. However, these subjects should be encouraged to nevertheless participate in the clinical part of the study: 3.Pregnant or nursing (including pumping for storage and feeding) 4.Contraindications to MRI examination (e.g., inability to hold breath, severearrhythmias, very low cardiac output, severe claustrophobia, or subjects with implanted defibrillators or other metallic devices not approved for MRI) 5.Suspected clinical instability or unpredictability of the clinical course during the study (e.g., due to previous surgery or acute stroke)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to describe the course of disease over time including, relapse, disability, cognitive function) and the healthcare resource utilization (HRU) (resource use, employment status), in relation to treatment with IFNB-1b.;Secondary Objective: The secondary objectives are to assess MRI, treatment history and current MS-specific medication, quality of life (QoL), fatigue, and depression, in the full former clinically-isolated syndrome (CIS) cohort as well as in subgroups of subjects.;Primary end point(s): As this is a long-term follow-up, the study is purely exploratory and descriptive in nature. Accordingly, a primary variable has not been selected. In order to describe disease course over time, the following efficacy variables of primary interest will be used: - Diagnosis and disease course according to McDonald Criteria (2001,2010) - Time to relapse (first, recurrent, annualized rate) - Time to conversion to CDMS - Time to conversion to SPMS - Disability (EDSS score) - Disability progression (confirmed and sustained 1-point EDSS progression; - confirmed 2.5-point EDSS progression) - Neurological status (Multiple Sclerosis Functional Composite (MSFC) score) - Cognitive function (MSFC: PASAT-3 score) - Time to use of ambulatory device - Time to dependence on ambulatory device - Time to use of wheelchair In order to describe resource use and employment status (primary study objective), the following HRU-based efficacy variables of primary interest will be used: - Employment status and MS impact on employment - Resource use: hospitalizations, visits to other specialists, and supportive care.;Timepoint(s) of evaluation of this end point: All data will be collected at a single clinical and MRI assessment visit, 15 years after the subject’s first clinical event. The assessments can be done at different time points where needed for logistic reasons. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables of interest will be: - Sustained attention, concentration, and information-processing speed (SDMT scores) - Relation of SDMT and FSMC - Relation of mental processing speed and MRI parameters. In order to assess QoL, fatigue, and depression (secondary study objectives), the following patient reported outcomes (PRO) will be used: - QoL (EQ-5D score, FAMS score) - Fatigue (FSMC score) - Depression (CES-D score). In order to describe MS-specific medication (secondary study objective), the following variables will be used: - Time to second line therapy - Time to first disease-modifying therapies (DMT) other than IFNB-1b The following other efficacy variables will be used: - MRI parameters: T1 lesion number and volume, cerebral volume - BMs Time to CDMS, to McDonald MS (diagnostic criteria 2001, 2010), and / or to SPMS;Timepoint(s) of evaluation of this end point: All data will be collected at a single clinical and MRI assessment visit, 15 years after the subject’s first clinical event. The assessments can be done at different time points where needed for logistic reasons. | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed