Multiple SclerosisNCT06737419
Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 5 Feb 2024
- 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 who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
- Aged 18 years or older at index date, and
- Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
- Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.
- Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.
- Conditions
- Multiple Sclerosis
- Keywords
- Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, 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 |
|---|---|---|
| Ofatumumab Cohort | Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Categorized by Number of Relapses
Measured: Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Measured: From Baseline up to Month 6 and Month 12
Secondary outcomes (22)
Age
Measured: Baseline
Number of Patients per Demographic Category
Demographics included:
- Gender
- Race
- Ethnicity
Measured: Baseline
Mean Duration of Disease
Measured: Baseline
Number of Patients by Most Recent Disease Course
Most recent disease course (in the last 6 months) included relapsing-remitting MS (RRMS)/clinically isolated syndrome (CIS), secondary progressive MS (SPMS), and primary progressive MS (PPMS).
Measured: Baseline
Number of Patients by Patient Determined Disease Steps (PDDS) Score
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Measured: Baseline, Month 6, Month 12
Number of Patients Categorized by Comorbidity
Measured: Baseline
Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)
Measured: Baseline
Number of Prior DMTs
Measured: Baseline
Number of Patients who Switched From a DMT to OMB
Measured: Baseline
Duration of Time Between Prior DMT and Initiating OMB Treatment
Measured: Baseline
Number of Patients by Most Recent Prior DMT
Most recent previous DMTs (in the last 6 months) included high efficacy and medium/low efficacy DMTs.
Measured: Baseline
Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation
Measured: Baseline
Number of Patients by Number of New Brain T2 Lesions
Measured: Baseline, Month 6, Month 12
Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions
Measured: Baseline, Month 6, Month 12
Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Measured: From Baseline up to Month 6 and Month 12
Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Measured: From Baseline up to Month 6 and Month 12
Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Measured: From Baseline up to Month 6 and Month 12
Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).
Measured: From Baseline up to Month 6 and Month 12
Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
When available, disability progression measures were calculated for patients. No evidence of disease activity (NEDA-2) status was defined and measured as the absence of clinical relapses and new/enlarging T2 and GdE lesions. NEDA-3 status was defined as components of NEDA-2 and absence of PDDS score worsening. NEDA-2 and NEDA-3 were only evaluated in patients who had all relevant parameters available for review.
Measured: From Baseline up to Month 6 and Month 12
Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Measured: From Baseline up to Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment
Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).
Measured: Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Jun 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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
- 175 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
- NCT06737419
- Sponsor's protocol ID
- COMB157GUS15
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
- ClinicalTrials.gov ID
- NCT06737419
- Acronym / sponsor ID
- COMB157GUS15
- Conditions
- Multiple Sclerosis
- Keywords
- Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 17 Dec 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.
This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab Cohort | – | –Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020). |
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 (5 listed)
- Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
- Aged 18 years or older at index date, and
- Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
- Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.
- Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)
Key exclusion criteria (0 listed)
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 Categorized by Number of Relapses
Time frame: Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
22 secondary outcomes
Age
Time frame: Baseline
Number of Patients per Demographic Category
Time frame: Baseline
Mean Duration of Disease
Time frame: Baseline
Number of Patients by Most Recent Disease Course
Time frame: Baseline
Number of Patients by Patient Determined Disease Steps (PDDS) Score
Time frame: Baseline, Month 6, Month 12
Number of Patients Categorized by Comorbidity
Time frame: Baseline
Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)
Time frame: Baseline
Number of Prior DMTs
Time frame: Baseline
Number of Patients who Switched From a DMT to OMB
Time frame: Baseline
Duration of Time Between Prior DMT and Initiating OMB Treatment
Time frame: Baseline
Number of Patients by Most Recent Prior DMT
Time frame: Baseline
Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation
Time frame: Baseline
Number of Patients by Number of New Brain T2 Lesions
Time frame: Baseline, Month 6, Month 12
Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions
Time frame: Baseline, Month 6, Month 12
Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment
Time frame: Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment
Time frame: Month 6 and Month 12
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 17 Dec 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 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 0 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 17 Dec 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 Categorized by Number of Relapses (time frame: Baseline, Month 6, Month 12). The study lists 2 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 17 Dec 2024.