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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab | Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | As described in the treatment arm. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease-Free Status at Month 12 | Month 12 | |
| Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year | Month 12 | |
| Annualized Relapse Rate at Month 12 in Comparison to the Previous Year | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease-Free Status at Months 24, 36 and 48 | Months 24, 36 and 48 | |
| Clinical Disease-free Status Every 6 Months | Every 6 months (Up to 48 months) | |
| Annualized Relapse Rate (ARR) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Amadora | 2720-276 | Portugal | |||
| Research Site |
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| 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). | Months 12, 24, 36 and 48 |
| MRI measures: T2, T1, T1 with Gadolinium (Gd) | Months 12, 24, 36 and 48 |
| Cognitive Impairment Using Symbol Digit Modalities Test (SDMT) | 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 | 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. | 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. | 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. | 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. | 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). | Months 12, 24, 36 and 48 |
| Angra do Heroísmo |
| 9700-049 |
| Portugal |
| Research Site | Aveiro | 3810-164 | Portugal |
| Research Site | Braga | 4710-243 | Portugal |
| Research Site | Coimbra | 3004-561 | Portugal |
| Research Site | Faro | 8000-386 | Portugal |
| Research Site | Funchal | 9000-177 | Portugal |
| Research Site | Guimarães | 4835-044 | Portugal |
| Research Site | Leiria | 2410-197 | Portugal |
| Research Site | Lisbon | 1649-028 | Portugal |
| Research Site | Loures | 2674-514 | Portugal |
| Research Site | Matosinhos Municipality | 4450-021 | Portugal |
| Research Site | Penafiel | 4564-007 | Portugal |
| Research Site | Porto | 4200-319 | Portugal |
| Research Site | Santa Maria da Feira | 4520-220 | Portugal |
| Research Site | Setúbal | 2910-446 | Portugal |
| Research Site | Viana do Castelo | 4904-858 | Portugal |
| Research Site | Vila Nova de Gaia | 4434-502 | Portugal |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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