Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: PT Classification code 10071068 Term: Clinically isolated syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with CIS or MS who have been treated at least once in BENEFIT Study 304747. 2. Patients who do not qualify for one or more interventional assessments (eg, MRI due to severe claustrophobia) are invited to participate in the other assessments of this study. 3. 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 468 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who meet any of the following criteria at the time of screening will be excluded from the study: ? Patients who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the patient’s ability to understand the purpose of the study. 2. Patients who meet any of the following criteria at the time of screening will be excluded from interventional MRI assessment. However, they should be encouraged to still participate in the study: ? Pregnant or nursing (including pumping for storage and feeding). ? Contraindications to MRI examination (eg, inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, or patients with implanted defibrillators or other metallic devices not approved for MRI). 3. Patients who meet any of the following criteria at the time of screening will be excluded from contrast media administration. However, they may undergo MRI assessment: ? Contraindication to the use of gadolinium-containing contrast agents (including patients who are suspected for or known to have nephrogenic systemic fibrosis). ? History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen, including drugs and contrast agents. ? Received any contrast agent within 72 hours prior to the study MRI, or scheduled to receive any contrast agent within 72 hours after the study MRI. ? Renal insufficiency, defined by baseline glomerular filtration rate. Estimated value = 30 mL/min/1.73 m2 derived from a serum creatinine result within 2 weeks prior to gadolinium-containing contrast agent injection is needed. Any patient on hemodialysis or peritoneal dialysis is excluded from contrast media administration. If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRI should be used. The core lab value should not be used if not available prior to the MRI. ? Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period. ? Known history of severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association Class IV) or known prolonged QT syndrome. ? Suspected clinical instability or unpredictability of the clinical course during the study (eg, due to previous surgery or acute stroke).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to describe the disease course (conversion to clinically-definite multiple sclerosis [CDMS]), change in disability, cognitive function, resource use, and employment status, in relation to treatment with Interferon beta-1b. Patients that cannot participate in a physical/face-to-face visit will have the option of being assessed via telephone on selected key outcomes, in an attempt to keep the patient ascertainment as high as possible.;Secondary Objective: The secondary objectives are to assess magnetic resonance imaging (MRI) and optic coherence tomography (OCT) parameters, treatment history, quality of life (QoL) parameters, fatigue and depression, the choice of MS-specific medication, and to investigate tolerability of Interferon beta-1b in the full former clinically-isolated syndrome (CIS) cohort as well as in subgroups of patients.;Primary end point(s): Regular face-to-face site visit: ? Relapses ? Conversion to CDMS, to MS by McDonald criteria (2001, 2010), and / or to secondary progressive multiple sclerosis (disease course) ? Expanded Disability Status Scale (EDSS) including DSS 3 and 6 information, Multiple Sclerosis Functional Composite (MSFC) (disability and disability progression) and Multiple Sclerosis Severity Score (MSSS) ? Paced Auditory Serial Addition Test (PASAT) and Symbol Digit Modalities Test (SDMT) (cognitive function) ? Resource use and employment status Telephone assessment for patients unable to visit site with selected outcomes: ? Relapses ? Telephone EDSS ? Conversion to CDMS (disease course) ? Resource use and vocational status ? Choice of and adherence to MS-specific medication ? Center of Epidemiological Studies Depression Scale (CES-D) (Depression) ? Fatigue Scale for Sensory and Motor Functions (FSMC) (fatigue) ? Functional Assessment of Multiple Sclerosis (FAMS) and European Quality of Life - 5 Dimensions (EQ-5D) (QoL);Timepoint(s) of evaluation of this end point: Relapses, disease course, E | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Regular face-to-face site visit: ? Diagnosis and disease course ? MRI parameters ? OCT parameters ? Visual acuity and ophthalmological findings ? CES-D (Depression) ? Fatigue Scale for Sensory and Motor Fatigue (Fatigue) ? Choice of and adherence to MS-specific medication ? FAMS and EQ-5D (QoL) ? Deoxyribonucleic acid [DNA], ribonucleic acid [RNA], biomarkers ? Vitamin D;Timepoint(s) of evaluation of this end point: Disease course and medication history - retrospective assessment since subject's last visit in any of the previous BENEFIT studies up to 11 years. MRI, OCT, depression, fatigue, QoL, genetics, evaluation of biomarkers and vitamin D - cross-sectional assessment (only or in addition to a retrospective assessment) at approximately 11 years after randomization. Please refer to Figure 4.2 in the Protocol for full details of assessments for the different endpoints in this study. | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed