Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: natalizumab (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Biogen Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Biogen
Overall contact: Biogen, Email: clinicaltrials@biogen.com
Summary
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
Clinical Details
Official title: A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Compare EDSS change categories with changes in MusiQoL
Secondary outcome: Cumulative probabilities of sustained improvement and progression in neurological disabilityCompare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL Compare EDSS change categories with EQ-5D Compare FSMC score with EQ-5D Compare MSISQ-19 scores with EQ-5D Comparison of BDI-FS with EQ-5D Compare SDMT scores with EQ-5D Rates of clinical relapses and relapses requiring steroid treatment Changes in the WPAI questionnaire Change in kind and percentage of occupation due to MS Change in the percentage of disability pension Incidence and number of SAEs and SUSARs
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Key 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)
Key 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
NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
Locations and Contacts
Biogen, Email: clinicaltrials@biogen.com
Research Site, Aarau, Switzerland; Recruiting
Research Site, Bern, Switzerland; Recruiting
Research Site, Lugano, Switzerland; Recruiting
Research Site, Luzern, Switzerland; Recruiting
Research Site, Muensterlingen, Switzerland; Not yet recruiting
Research Site, St. Gallen, Switzerland; Recruiting
Research Site, Wohlen, Switzerland; Recruiting
Research Site, Zurich, Switzerland; Recruiting
Additional Information
Starting date: March 2015
Last updated: July 31, 2015
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