Secondary Progressive Multiple SclerosisRESYZENCT06588387
A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis at 1 site in United States.
Trial summary
RESYZE was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in Spain, assessing secondary progressive multiple sclerosis (SPMS) patients in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 8 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Patients with SPMS, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from April 2021 to September 2022), regardless of whether they continued treatment or they did not.
- Patients who received at least 1 dose of siponimod treatment for SPMS with a 12-month observation period.
- Availability of the data for at least 12 months after siponimod initiation.
Who cannot join
- Patients with any contraindication to siponimod, according to applicable Summary of Product Characteristics (SmPC).
- Patients included in any clinical trial at any moment of the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Retrospective Study to Assess the Use of Siponimod (Mayzent) on Patients With Secondary Progressive Multiple Sclerosis in Clinical Practice in Spain - RESYZE Study
RESYZE was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in Spain, assessing secondary progressive multiple sclerosis (SPMS) patients in a real-world setting. Patients underwent clinical assessments and received their standard routine medical care, as determined by their treating physicians. The study used secondary data i.e., electronic medical records (EMR) from hospitals. Patients who met the eligibility criteria were selected from the EMR of each of the sites, to include adult SPMS diagnosed patients who received at least one dose of siponimod during the start of treatment period between April 2021 and 01 September 2022, with a 12-month observation period, regardless of whether or not they continued the treatment. The study compiled data that was available in the hospital EMR from each patient up to 24 months before the first siponimod dose, and 12 months after the first siponimod dose. Data were collected for each patient at regular intervals of 6/12 months and within a window period of ±45 days, as available.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Siponimod Cohort | Patients who received at least one dose of siponimod during the drug initiation period (April 2021 to September 2022). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Education Status
Education status included:
- No studies
- Primary education
- Secondary education
- Superior education
- Unknown or missing
Measured: Baseline
Number of Patients by Working Status
Working status included:
- Full-time
- Part-time
- Retired
- Incapacity for work
- Medical leave
- Unemployed
- Student
- Unknown or missing
Measured: Baseline
Body Mass Index (BMI)
Measured: Baseline
Number of Patients by Smoking Habit
Smoking habits included:
- Non-smoker
- Smoker
- Ex-smoker
- Unknown or missing
Measured: Baseline
Number of Patients by Alcohol Consumption
Alcohol consumption categories included:
- High risk consumer
- Low risk consumer
- Teetotaler
- Unknown or missing
Measured: Baseline
Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype
Genotype variants included:
- CYP2C9*1*1
- CYP2C9*1*2
- CYP2C9*1*3
- CYP2C9*2*2
- CYP2C9*2*3
- Other
Measured: Baseline
Time Since Multiple Sclerosis (MS) Diagnosis
Measured: Baseline
Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis
Measured: Baseline
Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment
Measured: Baseline
Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment
Measured: Baseline
Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment
Measured: Baseline
Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment
The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS score. The scale ranges from 0 to 10, with 0 being normal neurological exam and 10 being death due to MS.
Measured: Baseline
Number of Patients With Cognitive Decline Diagnosis
Measured: Baseline
EDSS Cognitive Subscale Score in Patients With Cognitive Decline
The EDSS cognitive subscale is used to grade the decrease in mentation inside the Cerebral Functional System of the EDSS scale. The scale ranges from 0 to 5, with 0 being normal (no decrease in mentation) and 5 being dementia, confusion and/or complete disorientation.
Measured: Baseline
Number of Patients by Comorbidity
Measured: Baseline
Secondary outcomes (31)
Number of Patients who Discontinued Siponimod Treatment
Measured: Up to 12 months
Number of Patients by Type of Siponimod Treatment Discontinuation
Treatment discontinuation categories included temporal and permanent discontinuation.
Measured: Up to 12 months
Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS
Measured: Up to 12 months
Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS
Measured: Up to 12 months
Number of Patients by Maintenance Siponimod Dose
Maintenance siponimod doses included 1 milligram (mg) and 2 mg.
Measured: Up to 12 months
Number of Patients who Needed a Siponimod Dose Modification
Measured: Up to 12 months
Number of Patients by Reason for Siponimod Dose Modification
Measured: Up to 12 months
Number of Patients who Needed First Dose Observation
Measured: Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During First Dose Observation
Measured: Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During Treatment With Siponimod
Measured: Up to 12 months
Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod
Adverse events of special interest included:
- Lymphopenia
- Macular edema
- Bradyarrhythmia
- Atrioventricular blockage
- Hypertension
- Hepatic enzymes elevation
- Epileptic crisis
- Infections
- Cutaneous neoplasia
- COVID-19
- Death
- Other
Measured: Up to 12 months
Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod
Measured: Up to 12 months
Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
Measured: Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
Measured: Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
Measured: Up to 12 months
Number of Patients Who Died During Treatment With Siponimod
Measured: Up to 12 Months
Number of Patients by Lymphopenia Grade During Treatment With Siponimod
Lymphopenia grades:
- Grade 1: less than lower limit of normal to 800 cells per cubic millimeters (cells/mm^3)
- Grade 2: less than 800 to 500 cells/mm^3
- Grade 3: less than 500 to 200 cells/mm^3
- Grade 4: less than 200 cells/mm^3
Measured: Baseline, Month 6, Month 12
Number of Patients With Confirmed Disability Progression During Treatment With Siponimod
Confirmed Disability Progression was determined by an increase of at least 1 point in the Expanded Disability Status (EDSS) score if the baseline EDSS was 5.5 or less, or an increase of 0.5 points in the EDSS score if the baseline EDSS score was greater than 5.5 confirmed in a second visit performed at least 3 months apart.
The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS scores, ranging from 0 (normal) to 10 (death due to MS).
Measured: Up to 12 months
Time to First Relapse
Measured: Up to 12 months
Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod
Measured: 12 months
Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod
Measured: Up to 12 months
Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod
Measured: Up to 12 months
Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod
Measured: Up to 12 months
Number of Patients With COVID-19 During the Study
Measured: Up to 12 months
Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection
Vaccination status included vaccinated and not vaccinated.
Measured: Up to 12 months
Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Nov 2022
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588387
- Sponsor's protocol ID
- CBAF312AES06
- Acronym
- RESYZE
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study to Assess the Use of Siponimod (Mayzent) on Patients With Secondary Progressive Multiple Sclerosis in Clinical Practice in Spain - RESYZE Study
- ClinicalTrials.gov ID
- NCT06588387
- Acronym / sponsor ID
- RESYZE / CBAF312AES06
- Conditions
- Secondary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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.
RESYZE was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in Spain, assessing secondary progressive multiple sclerosis (SPMS) patients in a real-world setting. Patients underwent clinical assessments and received their standard routine medical care, as determined by their treating physicians. The study used secondary data i.e., electronic medical records (EMR) from hospitals. Patients who met the eligibility criteria were selected from the EMR of each of the sites, to include adult SPMS diagnosed patients who received at least one dose of siponimod during the start of treatment period between April 2021 and 01 September 2022, with a 12-month observation period, regardless of whether or not they continued the treatment. The study compiled data that was available in the hospital EMR from each patient up to 24 months before the first siponimod dose, and 12 months after the first siponimod dose. Data were collected for each patient at regular intervals of 6/12 months and within a window period of ±45 days, as available.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siponimod Cohort | – | –Patients who received at least one dose of siponimod during the drug initiation period (April 2021 to September 2022). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- Patients with SPMS, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from April 2021 to September 2022), regardless of whether they continued treatment or they did not.
- Patients who received at least 1 dose of siponimod treatment for SPMS with a 12-month observation period.
- Availability of the data for at least 12 months after siponimod initiation.
Key exclusion criteria (2 listed)
- Patients with any contraindication to siponimod, according to applicable Summary of Product Characteristics (SmPC).
- Patients included in any clinical trial at any moment of the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients by Education Status
Time frame: Baseline
Education status included: * No studies * Primary education * Secondary education * Superior education * Unknown or missing
Number of Patients by Working Status
Time frame: Baseline
Working status included: * Full-time * Part-time * Retired * Incapacity for work * Medical leave * Unemployed * Student * Unknown or missing
Body Mass Index (BMI)
Time frame: Baseline
Number of Patients by Smoking Habit
Time frame: Baseline
Smoking habits included: * Non-smoker * Smoker * Ex-smoker * Unknown or missing
Number of Patients by Alcohol Consumption
Time frame: Baseline
Alcohol consumption categories included: * High risk consumer * Low risk consumer * Teetotaler * Unknown or missing
Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype
Time frame: Baseline
Genotype variants included: * CYP2C9*1*1 * CYP2C9*1*2 * CYP2C9*1*3 * CYP2C9*2*2 * CYP2C9*2*3 * Other
Time Since Multiple Sclerosis (MS) Diagnosis
Time frame: Baseline
Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis
Time frame: Baseline
Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment
Time frame: Baseline
Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment
Time frame: Baseline
Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment
Time frame: Baseline
Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment
Time frame: Baseline
The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS score. The scale ranges from 0 to 10, with 0 being normal neurological exam and 10 being death due to MS.
Number of Patients With Cognitive Decline Diagnosis
Time frame: Baseline
EDSS Cognitive Subscale Score in Patients With Cognitive Decline
Time frame: Baseline
The EDSS cognitive subscale is used to grade the decrease in mentation inside the Cerebral Functional System of the EDSS scale. The scale ranges from 0 to 5, with 0 being normal (no decrease in mentation) and 5 being dementia, confusion and/or complete disorientation.
Number of Patients by Comorbidity
Time frame: Baseline
31 secondary outcomes
Number of Patients who Discontinued Siponimod Treatment
Time frame: Up to 12 months
Number of Patients by Type of Siponimod Treatment Discontinuation
Time frame: Up to 12 months
Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS
Time frame: Up to 12 months
Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS
Time frame: Up to 12 months
Number of Patients by Maintenance Siponimod Dose
Time frame: Up to 12 months
Number of Patients who Needed a Siponimod Dose Modification
Time frame: Up to 12 months
Number of Patients by Reason for Siponimod Dose Modification
Time frame: Up to 12 months
Number of Patients who Needed First Dose Observation
Time frame: Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During First Dose Observation
Time frame: Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
Time frame: Up to 12 months
Number of Patients Who Died During Treatment With Siponimod
Time frame: Up to 12 Months
Number of Patients by Lymphopenia Grade During Treatment With Siponimod
Time frame: Baseline, Month 6, Month 12
Number of Patients With Confirmed Disability Progression During Treatment With Siponimod
Time frame: Up to 12 months
Time to First Relapse
Time frame: Up to 12 months
Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod
Time frame: 12 months
Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod
Time frame: Up to 12 months
Number of Patients With COVID-19 During the Study
Time frame: Up to 12 months
Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection
Time frame: Up to 12 months
Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study
Time frame: Up to 12 months
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 19 Sep 2024.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis at 1 site in United States.
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 3 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Number of Patients by Education Status (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.