Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab (PROTYS)
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|ClinicalTrials.gov Identifier: NCT02386566|
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : September 13, 2018
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|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: natalizumab|
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab|
|Actual Study Start Date :||March 20, 2015|
|Actual Primary Completion Date :||January 28, 2018|
|Actual Study Completion Date :||January 28, 2018|
natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland
As described in the treatment arm
- Compare EDSS change categories with changes in MusiQoL [ Time Frame: At 1 year after initiating natalizumab treatment ]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.
- Cumulative probabilities of sustained improvement and progression in neurological disability [ Time Frame: At 1 year after initiating natalizumab treatment ]
- Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL [ Time Frame: Up to 1 year after initiating natalizumab treatment ]
- Compare EDSS change categories with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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).
- Compare FSMC score with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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.
- Compare MSISQ-19 scores with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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).
- Comparison of BDI-FS with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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.
- Compare SDMT scores with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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.
- Rates of clinical relapses and relapses requiring steroid treatment [ Time Frame: Up to 1 year after initiating natalizumab treatment ]
- Changes in the WPAI questionnaire [ Time Frame: Up to 1 year after initiating natalizumab treatment ]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.
- Change in kind and percentage of occupation due to MS [ Time Frame: At 1 year after initiating natalizumab treatment ]
- Change in the percentage of disability pension [ Time Frame: At 1 year after initiating natalizumab treatment ]
- Incidence and number of SAEs and SUSARs [ Time Frame: Up to 1 year after initiating natalizumab treatment ]
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386566
|Research site - private practice|
|Study Director:||Medical Director||Biogen|
|Other Study ID Numbers:||
|First Posted:||March 12, 2015 Key Record Dates|
|Last Update Posted:||September 13, 2018|
|Last Verified:||September 2018|
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs