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…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The objective of this study is to obtain clinical long-term data, magnetic
resonance imaging (MRI), and optic coherence tomography (OCT) information after
early or delayed interferon-beta-1b treatment in patients with a first
demyelinating event suggestive of multiple sclerosis (MS) enrolled in the
Betaferon®/Betaseron® in Newly Emerging Multiple Sclerosis for Initial
Treatment (BENEFIT) study (304747) for an average of 11 years after their first
clinical event. An integrated statistical analysis will include data from the
BENEFIT (304747), the BENEFIT follow-up (305207), and the BENEFIT extension
(311129) studies, and this BENEFIT 11 study (16401).
Study 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.
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.
Study design
Multicenter, international, cross-sectional, interventional, observational
follow-up study in MS patients
This observational study may include all patients who were randomized into and
treated at least once in the BENEFIT Study 304747, inclusive of patients who
prematurely discontinued study participation in that study, and Studies 305207
or 311129, and patients who did not transfer from Study 304747 to Study 305207
as well as patients who did not participate in Study 311129.
In this study, one (and up to four, if required, for MRI and OCT assessments)
clinical visits are planned. In addition to the clinical assessment, a
telephone based assessment has been added to allow for more complete inclusion
of all patients. The telephone-based, validated assessment will capture a
small number of key outcome variables exclusively for patients who are unable
to visit the site in-person, and will be performed by the investigator*s staff.
Study burden and risks
Regular face-to-face site visit
Variables of primary interest:
* 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 and Symbol Digit Modalities Test
(cognitive function)
* Resource use and vocational status
Variables of secondary interest:
* Diagnosis and disease course
* MRI parameters
* OCT parameters
* Visual acuity and ophthalmological findings
* Center of Epidemiological Studies Depression Scale (CES-D) (Depression)
* Fatigue Scale for Sensory and Motor Fatigue (Fatigue)
* Choice of and adherence to MS-specific medication
* Functional Assessment of Multiple Sclerosis (FAMS), and European Quality of
Life * 5 Dimensions (EQ-5D) (QoL)
* Deoxyribonucleic acid [DNA], ribonucleic acid [RNA], biomarkers
* Vitamin D
Telephone assessment for patients unable to visit site with selected outcomes
* Relapses
* Telephone EDSS [Error! Reference source not found.]
* Conversion to CDMS (disease course)
* Resource use and vocational status
* Choice of and adherence to MS-specific medication
* CES-D (Depression)
* FAMS, EQ-5D (QoL)
Müllerstrae 178
Berlin 13353
DE
Müllerstrae 178
Berlin 13353
DE
Listed location countries
Age
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
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 [< 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44539.096.13 |