The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).
Study Type
OBSERVATIONAL
Enrollment
60
As described in the treatment arm.
Research Site
Amadora, Portugal
Research Site
Angra do Heroísmo, Portugal
Research Site
Aveiro, Portugal
Overall Disease-Free Status at Month 12
Time frame: Month 12
Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
Time frame: Month 12
Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
Time frame: Month 12
Overall Disease-Free Status at Months 24, 36 and 48
Time frame: Months 24, 36 and 48
Clinical Disease-free Status Every 6 Months
Time frame: Every 6 months (Up to 48 months)
Annualized Relapse Rate (ARR)
Time frame: Months 12, 24, 36 and 48
Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)
The EDSS is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).
Time frame: Months 12, 24, 36 and 48
MRI measures: T2, T1, T1 with Gadolinium (Gd)
Time frame: Months 12, 24, 36 and 48
Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)
Time frame: Months 12, 24, 36 and 48
Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire
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Research Site
Braga, Portugal
Research Site
Coimbra, Portugal
Research Site
Faro, Portugal
Research Site
Funchal, Portugal
Research Site
Guimarães, Portugal
Research Site
Leiria, Portugal
Research Site
Lisbon, Portugal
...and 8 more locations
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages ranging from 0-100%, with higher numbers indicating greater impairment and less productivity.
Time frame: Months 12, 24, 36 and 48
Quality of life (QoL) Assessed Using Fatigue Severity Scale
The FSS is a self-assessment questionnaire that provides a score as a measurement of the severity of fatigue. It consists of 9 questions scored from 1 to 7. A low value (e.g., 1); indicates strong disagreement with the statement, whereas a high value (e.g., 7); indicates strong agreement. A total score of 36 or more suggests presence of fatigue.
Time frame: Months 12, 24, 36 and 48
QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test
MSFC has 2 component- timed 25-foot walk (T25FW) and 9-hole peg test (9HPT) \[dominant and nondominant hands\]. The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT-2)/2, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z \>0) or lower (Z \<0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.
Time frame: Months 12, 24, 36 and 48
QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)
BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
Time frame: Months 12, 24, 36 and 48
QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)
MSIS-29 is a brief self-administered instrument measuring physical (20 items) and psychological (9 items) impact of Multiple Sclerosis (MS). Each of the 29 items on MSIS-29 tool is a question that ask for participants views about the impact of MS on their day to day lives. Each item is scored on 1 to 5 (1=Not at all; 5=Extremely).
Time frame: Months 12, 24, 36 and 48