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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| natalizumab | natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | As described in the treatment arm |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare EDSS change categories with changes in MusiQoL | The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. The MusiQOL is a multidimensional Health Related Quality of Life (HRQoL) instrument that provides information based on the views and perceptions of the participants. | At 1 year after initiating natalizumab treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative probabilities of sustained improvement and progression in neurological disability | At 1 year after initiating natalizumab treatment | |
| Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL | Up to 1 year after initiating natalizumab treatment |
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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 | Aarau | Switzerland | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36727105 | Derived | Achtnichts L, Zecca C, Findling O, Kamm CP, Mueller S, Kuhle J, Lutterotti A, Gobbi C, Viviani C, Villiger-Borter E, Nedeltchev K. Correlation of disability with quality of life in patients with multiple sclerosis treated with natalizumab: primary results and post hoc analysis of the TYSabri ImPROvement study (PROTYS). BMJ Neurol Open. 2023 Jan 26;5(1):e000304. doi: 10.1136/bmjno-2022-000304. eCollection 2023. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Compare EDSS change categories with EQ-5D | The EQ-5D is a two-part instrument that consists of the following administered together: 1) EQ-5D-5L- The descriptive system comprises the same 5 dimensions as the EQ-5D-3L (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ-VAS describes the respondent's self-rated health on a vertical visual analog scale (VAS). | Up to 1 year after initiating natalizumab treatment |
| Compare FSMC score with EQ-5D | FSMC provides differential quantification and graduation of cognitive and motor fatigue. The total score ranges from 0 to 100 with higher scores indicating more fatigue. | Up to 1 year after initiating natalizumab treatment |
| Compare MSISQ-19 scores with EQ-5D | MSIS-Q is a 19-question survey to assess sexual QoL in MS patients. The scoring is based on a scale ranging from 1 (never interfered with my sexual activity or satisfaction) to 5 (always interfered with my sexual activity or satisfaction). | Up to 1 year after initiating natalizumab treatment |
| Comparison of BDI-FS with EQ-5D | The Beck Depression Inventory (BDI) as measured by the BDI-FS is a 7-item multiple-choice self-report inventory for measuring the severity of depression in MS. | Up to 1 year after initiating natalizumab treatment |
| Compare SDMT scores with EQ-5D | SDMT is a screening test for cognitive impairment. It assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed. SDMT scores are highly correlated to Magnetic Resonance Imaging (MRI) derived measures of disease burden and disability progression in MS patients. | Up to 1 year after initiating natalizumab treatment |
| Rates of clinical relapses and relapses requiring steroid treatment | Up to 1 year after initiating natalizumab treatment |
| Changes in the 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, with higher numbers indicating greater impairment and less productivity. | Up to 1 year after initiating natalizumab treatment |
| Change in kind and percentage of occupation due to MS | At 1 year after initiating natalizumab treatment |
| Change in the percentage of disability pension | At 1 year after initiating natalizumab treatment |
| Incidence and number of SAEs and SUSARs | Up to 1 year after initiating natalizumab treatment |
| Basel |
| Switzerland |
| Research Site | Bern | Switzerland |
| Research site - private practice | Lucerne | Switzerland |
| Research Site | Lugano | Switzerland |
| Research Site | Wohlen | Switzerland |
| Research Site | Zurich | Switzerland |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |