Primary: Does immunomodulation brought about by interferon beta-1a (Rebif) enhance or prolong functional reorganization in subjects with RRMS?Secondary: Does interferon beta-1a (Rebif) also affects functional connectivity as measured by resting-…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints: The mean change of each subject affected by RRMS or
relapsing SPMS from baseline in functional connectivity (resting-state) fMRI at
month 24.
Secondary outcome
Secondary Endpoints: Clinicial measures (progression of disability) will be
measured through change in Extended Disability Status Scale (EDSS) and Multiple
Sclerosis Functional Composite (MSFC). Clinical measures (progression of
disease activity) as measured through the number of relapses and annualized
relapse rate. Cognitive decline as measured by change in Brief Repeatable
Battery * Neuropsychological tests (BRB-N) scores. Correlations fMRI and
clinical/cognitive outcomes. And Requirement for treatment with corticosteroids
due to relapses.
Background summary
Interferons have antiviral, anti-proliferative and immunomodulatory effects. In
response to CNS (Central Nervous System) damage - including inflammation in MS
- the brain has to functionally adapt. We hypothesize that the immunomodulatory
effects of interferon beta-1a will amplify the effect on functional adaptation.
This enhanced functional adaptation - where the function of damaged brain areas
is gradually taken over by other - non-damaged * areas - will have a positive
outcome on disability, progression and cognitive decline.
Study objective
Primary: Does immunomodulation brought about by interferon beta-1a (Rebif)
enhance or prolong functional reorganization in subjects with RRMS?
Secondary: Does interferon beta-1a (Rebif) also affects functional connectivity
as measured by resting-state functional Magnetic Resonance Imaging (fMRI) in
subjects affected by relapsing SPMS? Does enhanced functional adaptation,
induced by interferon beta-1a (Rebif) treatment, will reduce physical
disability and cognitive decline in subjects affected by RRMS and relapsing
SPMS? Does interferon beta-1a (Rebif) enhance functional brain adaptation over
time, both in subjects affected by RRMS and relapsing SPMS?
Study design
The study is a prospective, single-centre, observational patient-control study
assessing the effect of interferon beta-1a on functional adaptation in RRMS and
relapsing SPMS patients.
Study burden and risks
All subjects need four visits at four timepoints for fMRI, BRB-N and
bloodsampling. All patient subjects will also undergo neurological examination
(EDSS, MSFC) at the four timepoints.
De Boelelaan 1118
1081 HZ Amsterdam
NL
De Boelelaan 1118
1081 HZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
age 18-65
RRMS or relapsing SPMS
Meet safety criteria for MRI
Group 1: Subjects affected by RRMS starting or recently started with Interferon beta-1a treatment
Group 2: Subjects affected by relapsing SPMS on interferon beta-1a treatment.
Group 3: Untreated Subjects affected by RRMS or relapsing SPMS
Group 4: Healthy controls
Exclusion criteria
MS other than RRMS or relapsing SPMS
presence or history of psychiatric disease
presence or history of neurological disease
presence or history of alcohol or drug abuse
presence of contra-indications for MRI
presence of contra-indications for Rebif
Use of immunosupressive agents
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-003570-89-NL |
| CCMO | NL37559.029.11 |