Multiple SclerosisPROTYSNCT02386566
Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
An observational study of Multiple Sclerosis, run by Biogen at 7 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- natalizumab
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 20 Mar 2015to 28 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
Research Site
Aarau
Research Site
Basel
Research Site
Bern
Research site - private practice
Lucerne
Research Site
Lugano
Research Site
Wohlen
Research Site
Zurich
About this study
Official title: A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab
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
- Conditions
- Multiple Sclerosis
- Being tested
- natalizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabDrug
Also called Tysabri, BG00002
As described in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| natalizumab | natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland Receives: Drug: natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year after initiating natalizumab treatment
Secondary outcomes (12)
Cumulative probabilities of sustained improvement and progression in neurological disability
Measured: At 1 year after initiating natalizumab treatment
Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL
Measured: Up to 1 year after initiating natalizumab treatment
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 1 year after initiating natalizumab treatment
Rates of clinical relapses and relapses requiring steroid treatment
Measured: 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.
Measured: Up to 1 year after initiating natalizumab treatment
Change in kind and percentage of occupation due to MS
Measured: At 1 year after initiating natalizumab treatment
Change in the percentage of disability pension
Measured: At 1 year after initiating natalizumab treatment
Incidence and number of SAEs and SUSARs
Measured: Up to 1 year after initiating natalizumab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start20 Mar 2015
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386566
- Sponsor's protocol ID
- CHE-TYS-12-10341
- Acronym
- PROTYS
- Status last verified
- Sep 2018
- First submitted
- 6 Feb 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36727105
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab
- ClinicalTrials.gov ID
- NCT02386566
- Acronym / sponsor ID
- PROTYS / CHE-TYS-12-10341
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| natalizumab | – | Drug: natalizumabnatalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: Tysabri, BG00002As described in the treatment arm | Drug | natalizumab |
Primary outcome
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.
12 secondary outcomes
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
Compare FSMC score with EQ-5D
Time frame: Up to 1 year after initiating natalizumab treatment
Compare MSISQ-19 scores with EQ-5D
Time frame: Up to 1 year after initiating natalizumab treatment
Comparison of BDI-FS with EQ-5D
Time frame: Up to 1 year after initiating natalizumab treatment
Compare SDMT scores with EQ-5D
Time frame: Up to 1 year after initiating natalizumab treatment
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 36727105Achtnichts 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 7 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare EDSS change categories with changes in MusiQoL (time frame: At 1 year after initiating natalizumab treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.