The effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS)

The effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS) - Interferon beta-1a and functional adaptation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35491

Enrollment

100

Registered

2011-11-02

Start date

2011-11-21

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS multiple sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results