MS - progress observation MS
Conditions
Interventions
None listed
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
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
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 Gadobutrol-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 magnetic resonance angiography (MRA), or scheduled to receive any contrast agent within 72 hours after the study MRA. This also applies to any computed tomography angiogram (CTA) scheduled during the course of the study. * 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 gadobutrol injection 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 MRA should be used. The core lab value should not be used if not available prior to the MRA/CTA. * 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 [
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess MRI and OCT parameters, treatment history, quality of life (QoL) parameters 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. | — |
Countries
Netherlands
Outcome results
None listed