Multiple SclerosisNCT06760624
Effectiveness of Ofatumumab in Real-world Practice
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 779 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 15 Jan 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
- Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
- One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
- One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision [ICD-10] code G35.xx) any time before the index date and up to 6 months after the index date.
- Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
- Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration [FDA] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period on 31 December 2023.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
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 MS Cohort | Adult patients diagnosed with MS who were treated with ofatumumab. | |
| Anti-CD20-naïve Sub-cohort | Adult patients diagnosed with MS who were treated with ofatumumab and had not received anti-CD20 treatment. | |
| Anti-CD20-experienced Sub-cohort | Adult patients diagnosed with MS who were treated with ofatumumab and had previously received anti-CD20 treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR) in the Pre-Index Period
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.
Measured: 12 months
ARR in the Post-index Period
The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.
Measured: An average of approximately 16 months
Incidence Rate Ratio
Incidence rate ratio was measured to evaluate the change in MS-related ARR in the pre- versus the post-index period.
The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
Measured: An average of approximately 16 months
Secondary outcomes (18)
Age
Measured: Baseline
Number of Patients per Demographic Category
Demographic categories included:
- Age Group (18-34, 35-44, 45-54, 55-64, and 65+ years)
- Gender
- Race
- Region
- Insurance Payer type
- Year of Index date (2020, 2021, 2022)
Measured: Baseline
Mean Deyo-Charlson Comorbidity Index
Deyo-Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2).
Measured: Baseline
Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders
PDG captures a list of mental health disorders a patient may have at study baseline. The following are the list of PDGs:
- Adult personality disorders
- Anxiety disorders
- Behavioral syndromes
- Childhood and adolescent psychiatric syndromes
- Intellectual disabilities
- Psychiatric disorders with known physiological causes
- Mood disorders
- Pervasive disorders
- Schizophrenia
- Substance use
Measured: Baseline
Number of Patients Categorized by Top Five Selected Comorbidities
Top five selected comorbidities included osteoarthritis, dyslipidemia, depression, hypertension, and sleep disorders.
Measured: Baseline
Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions
Top five MS-related symptoms and secondary conditions included anxiety, fatigue or malaise, sensory problems, eye symptoms, and urinary tract infection.
Measured: Baseline
Number of Patients Categorized by MS Disability Level
MS disability level was based on observance of Expanded Disability Status Scale (EDSS)-related symptoms and durable medical equipment (DME) use observed in claims data weighted by severity score. Disability levels and definitions were as follows: Severe = Defined as having ≥1 EDSS-related symptom with severity score = 3 in any functional system; Moderate: Defined as having ≥1 EDSS-related symptom with severity score = 2 in any functional system, or having ≥2 functional systems with severity score = 1; Mild: Defined as having only one EDSS-related symptom with severity score = 1 or having no EDSS-related symptoms observed during the measurement period.
Measured: Baseline
Number of Patients Categorized by DMT Used in the Pre-index Period
DMT categories included:
- Any DMT
- Low/moderate efficacy therapy
- High efficacy therapy
- No DMT
Measured: Baseline
Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim.
Measured: 12 months
Pre-index HCRU: Number of Days of MS-related Hospitalization PPY
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim.
Measured: 12 months
Pre-index HCRU: Number of MS-related Healthcare Visits PPY
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. MS-related healthcare visits included emergency department visits and outpatient visits.
Measured: 12 months
Post-index HCRU: Number of MS-related Hospitalizations PPY
The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim.
Measured: An average of approximately 16 months
Post-index HCRU: Number of Days of MS-related Hospitalization PPY
The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim.
Measured: An average of approximately 16 months
Post-index HCRU: Number of MS-related Healthcare Visits PPY
The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim. MS-related healthcare visits included emergency department visits and outpatient visits.
Measured: An average of approximately 16 months
Incidence Rate Ratio of MS-related Hospitalizations
Incidence rate ratio was measured to evaluate the change in MS-related hospitalizations in the pre- versus the post-index period.
The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
Measured: An average of approximately 16 months
Incidence Rate Ratio of Days of MS-related Hospitalizations
Incidence rate ratio was measured to evaluate the change in days of MS-related hospitalizations in the pre- versus the post-index period.
The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
Measured: An average of approximately 16 months
Incidence Rate Ratio of MS-related Emergency Department Visits
Incidence rate ratio was measured to evaluate the change in MS-related emergency department visits in the pre- versus the post-index period.
The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
Measured: An average of approximately 16 months
Incidence Rate Ratio of MS-related Outpatient Visits
Incidence rate ratio was measured to evaluate the change in MS-related outpatient visits in the pre- versus the post-index period.
The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
Measured: An average of approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start24 Oct 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 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
- 779 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
- NCT06760624
- Sponsor's protocol ID
- COMB157AUS21
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ofatumumab in Real-world Practice
- ClinicalTrials.gov ID
- NCT06760624
- Acronym / sponsor ID
- COMB157AUS21
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 7 Jan 2025 (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 used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration [FDA] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period on 31 December 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab MS Cohort | – | –Adult patients diagnosed with MS who were treated with ofatumumab. |
| Anti-CD20-naïve Sub-cohort | – | –Adult patients diagnosed with MS who were treated with ofatumumab and had not received anti-CD20 treatment. |
| Anti-CD20-experienced Sub-cohort | – | –Adult patients diagnosed with MS who were treated with ofatumumab and had previously received anti-CD20 treatment. |
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)
- Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
- One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
- One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision [ICD-10] code G35.xx) any time before the index date and up to 6 months after the index date.
- Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
- Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.
Key exclusion criteria (1 listed)
- None.
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
Annualized Relapse Rate (ARR) in the Pre-Index Period
Time frame: 12 months
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.
ARR in the Post-index Period
Time frame: An average of approximately 16 months
The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.
Incidence Rate Ratio
Time frame: An average of approximately 16 months
Incidence rate ratio was measured to evaluate the change in MS-related ARR in the pre- versus the post-index period. The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.
18 secondary outcomes
Age
Time frame: Baseline
Number of Patients per Demographic Category
Time frame: Baseline
Mean Deyo-Charlson Comorbidity Index
Time frame: Baseline
Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders
Time frame: Baseline
Number of Patients Categorized by Top Five Selected Comorbidities
Time frame: Baseline
Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions
Time frame: Baseline
Number of Patients Categorized by MS Disability Level
Time frame: Baseline
Number of Patients Categorized by DMT Used in the Pre-index Period
Time frame: Baseline
Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)
Time frame: 12 months
Pre-index HCRU: Number of Days of MS-related Hospitalization PPY
Time frame: 12 months
Pre-index HCRU: Number of MS-related Healthcare Visits PPY
Time frame: 12 months
Post-index HCRU: Number of MS-related Hospitalizations PPY
Time frame: An average of approximately 16 months
Post-index HCRU: Number of Days of MS-related Hospitalization PPY
Time frame: An average of approximately 16 months
Post-index HCRU: Number of MS-related Healthcare Visits PPY
Time frame: An average of approximately 16 months
Incidence Rate Ratio of MS-related Hospitalizations
Time frame: An average of approximately 16 months
Incidence Rate Ratio of Days of MS-related Hospitalizations
Time frame: An average of approximately 16 months
Incidence Rate Ratio of MS-related Emergency Department Visits
Time frame: An average of approximately 16 months
Incidence Rate Ratio of MS-related Outpatient Visits
Time frame: An average of approximately 16 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 25 Mar 2025.
- Results for COMB157AUS21 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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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 1 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 25 Mar 2025. 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?
Annualized Relapse Rate (ARR) in the Pre-Index Period (time frame: 12 months). The study lists 3 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 25 Mar 2025.