The effect of interferon beta-1a treatment on adaptability of the brain in patients with MS

Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Multiple sclerosis
MedDRA version: 14.0Level: PTClassification code 10004504Term: Beta interferon therapySystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2011-003570-89-NL

Lead Sponsor: VU University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: Does immunomodulation brought about by interferon beta-1a (Rebif) enhance or prolong functional reorganization in subjects with RRMS?<br>;Secondary Objective: 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?;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: at 24 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: at 6, 12 and 24 months;Secondary end point(s): 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.