Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-20

Study Completion Date

2018-01-28

Brief Summary

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The primary objective of the study is to determine the association between prospectively measured disability (Expanded Disability Status Scale \[EDSS\]) with quality of life (Multiple Sclerosis International Quality of Life Questionnaire \[MusiQoL\]) at 3-month intervals up to 1 year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The secondary objectives of this study are as follows: To evaluate the cumulative probability of sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function \[FSMC\]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 \[MSISQ-19\]), depression (Beck Depression Inventory-Fast Screen \[BDI-FS\]) and neurocognitive function (Symbol Digit Modalities Test \[SDMT\]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to 6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse) and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe changes in work impairment (Work Productivity and Activity Impairment in MS \[WPAI-MS\]) at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe any change in the percentage of disability pension and occupation after 1 year of natalizumab treatment; To record the incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) throughout the study

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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natalizumab

natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland

natalizumab

Intervention Type DRUG

As described in the treatment arm

Interventions

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natalizumab

As described in the treatment arm

Intervention Type DRUG

Other Intervention Names

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Tysabri BG00002

Eligibility Criteria

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Inclusion Criteria

* Subjects that have a confirmed diagnosis of RRMS, as per the 2010 revised McDonald criteria
* Subjects satisfying the therapeutic indication of natalizumab, as described in the local product label and confirmed by the Investigator. (Patients with previous treatment with natalizumab are also considered to be eligible only if the last natalizumab infusion was at least 1 year before the screening visit of this study)
* Decision for a treatment with natalizumab has been made before screening
* Patients with an EDSS score of 2.0-5.5 (both limits inclusive)

Exclusion Criteria

* Patients with a diagnosed co-existing brain pathology other than MS, which in the judgement of the investigator impacts the value of EDSS or QoL.
* Pure spinal manifestation of demyelination
* Diagnosis of primary or secondary progressive MS
* Any change in concomitant medication known to affect cognition or bladder function
* A history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No