Multiple SclerosisNCT05528666
Risk Perception in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High Efficacy Therapy (HET) and Non High Efficacy Therapy (Non-HET)
- How many people
- 4,361 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 17 Sep 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at index date, and whose physician decided to switch their treatment.
Who may be able to join
- Patients included in the database with a diagnosis of RRMS and SPMS.
- Patients with current treatment at the index date.
- Patients with previous treatment at the index date.
- Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date.
- Patients (males \& females) with 18 years or older at index date.
Who cannot join
- Patients included in the database with the diagnosis of primary progressive MS (PPMS).
- Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
Read the detailed description
The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset.
Study period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).
Identification period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).
Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 \& Q2 2021).
- Conditions
- Multiple Sclerosis
- Being tested
- High Efficacy Therapy (HET), Non High Efficacy Therapy (Non-HET)
- Keywords
- Multiple sclerosis (MS),, Disease-modifying therapies (DMTs),, High efficacy treatments (HETs),, Nonhigh efficacy treatments (Non-HETs)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Efficacy Therapy (HET)Other
HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.
Non High Efficacy Therapy (Non-HET)Other
Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
| Study group | Role | What they receive |
|---|---|---|
| Overall cohort | Included all patients | |
| Previous Non-HET | Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. Receives: Other: Non High Efficacy Therapy (Non-HET) | |
| Previous HET | HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. Receives: Other: High Efficacy Therapy (HET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who were switched based on risk perception (infections, malignancies, others)
Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.
Measured: Throughout the study, approximately 5 years (2017 to 2021)
Secondary outcomes (11)
Number of patients with ranking of the frequency of switches due to risk perception
Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.
Measured: Throughout the study, approximately 5 years (2017 to 2021)
Proportion of patients who switched due to lack of efficacy
Proportion of patients who switched due to lack of efficacy due to new or enlarging lesions on MRI, increase in the frequency and/or severity of the relapses, progression in physical disability measured by EDSS or patient compliance issues between groups were reported.
Measured: Throughout the study, approximately 5 years (2017 to 2021)
Proportion of patients who changed treatment group versus patients who continued in the same treatment group
Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported.
Measured: Throughout the study, approximately 5 years (2017 to 2021)
Number of relapses
Number of relapses were reported.
Measured: Baseline
Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: Baseline
Age
Age information reported
Measured: Baseline
Gender
Gender information reported
Measured: Baseline
Number of patients: Employment status
Patient employment status reported
Measured: Baseline
Number of patients with Initial MS diagnosis
Number of patients with Initial MS diagnosis were reported.
Measured: Baseline
Number of patients with Current MS diagnosis
Number of patients with Current MS diagnosis were reported.
Measured: Baseline
Number of patients with previous disease modifying treatment
Number of patients with previous disease modifying treatment were reported.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start9 Sep 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Retrospective
- Enrolment
- 4,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528666
- Sponsor's protocol ID
- COMB157G3001
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Perception in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05528666
- Acronym / sponsor ID
- COMB157G3001
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis (MS),, Disease-modifying therapies (DMTs),, High efficacy treatments (HETs),, Nonhigh efficacy treatments (Non-HETs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,361 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 6 Sep 2022 (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.
This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
Detailed description
The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset.
Study period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).
Identification period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).
Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 \& Q2 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | –Included all patients |
| Previous Non-HET | – | Other: Non High Efficacy Therapy (Non-HET)Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. |
| Previous HET | – | Other: High Efficacy Therapy (HET)HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at index date, and whose physician decided to switch their treatment.
Key inclusion criteria (5 listed)
- Patients included in the database with a diagnosis of RRMS and SPMS.
- Patients with current treatment at the index date.
- Patients with previous treatment at the index date.
- Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date.
- Patients (males \& females) with 18 years or older at index date.
Key exclusion criteria (2 listed)
- Patients included in the database with the diagnosis of primary progressive MS (PPMS).
- Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.
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 |
|---|---|---|
| High Efficacy Therapy (HET)HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. | Other | Previous HET |
| Non High Efficacy Therapy (Non-HET)Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. | Other | Previous Non-HET |
Primary outcome
Proportion of patients who were switched based on risk perception (infections, malignancies, others)
Time frame: Throughout the study, approximately 5 years (2017 to 2021)
Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.
11 secondary outcomes
Number of patients with ranking of the frequency of switches due to risk perception
Time frame: Throughout the study, approximately 5 years (2017 to 2021)
Proportion of patients who switched due to lack of efficacy
Time frame: Throughout the study, approximately 5 years (2017 to 2021)
Proportion of patients who changed treatment group versus patients who continued in the same treatment group
Time frame: Throughout the study, approximately 5 years (2017 to 2021)
Number of relapses
Time frame: Baseline
Expanded Disability Status Scale (EDSS)
Time frame: Baseline
Age
Time frame: Baseline
Gender
Time frame: Baseline
Number of patients: Employment status
Time frame: Baseline
Number of patients with Initial MS diagnosis
Time frame: Baseline
Number of patients with Current MS diagnosis
Time frame: Baseline
Number of patients with previous disease modifying treatment
Time frame: Baseline
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 8 Nov 2022.
- Results for COMB157G3001 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Multiple Sclerosis, run by Novartis Pharmaceuticals 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 5 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 8 Nov 2022. 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?
Proportion of patients who were switched based on risk perception (infections, malignancies, others) (time frame: Throughout the study, approximately 5 years (2017 to 2021)). 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 8 Nov 2022; AzTrials last refreshed its copy on 28 Oct 2026.