Multiple SclerosisNCT05576779
Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ofatunumab
- How many people
- 2,101 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 31 Dec 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prescription claims for ofatumumab or other DMTs of interest.
Who may be able to join
- Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.
- -. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
- Patients with linkage to the Dx database.
Who cannot join
- No exclusion criteria were applied to patients in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World
This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.
Read the detailed description
The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.
Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.
The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.
- Conditions
- Multiple Sclerosis
- Being tested
- Ofatunumab
- Keywords
- Multiple sclerosis,, ofatumumab,, disease-modifying therapy,, COVID-19
- Medical subject headings
- Multiple Sclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatunumabOther
All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort Receives: Other: Ofatunumab | |
| Non-ofatumumab | patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients initiating ofatumumab based on DMT use
The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Secondary outcomes (34)
Age
Age information was reported
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Gender
Gender information was reported
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Geographic region
Northeast, Midwest, South, West, Unknown
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: State level (Geographic region)
The geographical heat map of ofatumumab utilization at the state level was presented.
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Insurance type
Cash, Commercial, Medicare, Medicare Part D, Medicaid, Unknown
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Payer
CVS, Aetna etc
Measured: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Follow-up time
Ofatumumab persistence was assessed over the variable follow-up time.
Measured: Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Number of patients: Pre-index Charlson comorbidity index (CCI)
Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. omorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2)
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index comorbidities
Number of patients with list of comorbidities were reported
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in inpatient settings
Number of patients with MS relapses were reported
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in outpatient settings
Number of patients with MS relapses were reported
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in all patients
Number of patients with MS relapses were reported
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in patients with at least 1 relapse
Number of patients with MS relapses were reported
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Claims-Based Disability Score
Pre-index MS-related symptoms and secondary conditions (n, %) based on a Claims-Based Disability Score (e.g., sensory problems, eye symptoms, pyramidal symptoms, bladder/bowel symptoms, fatigue/malaise, muscular weakness, durable medical equipment utilization.
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of pre-index Brain and Spinal MRI scans
Categorized as: No MRI, 1, 2, 3+
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Hepatitis B virus screening
Yes/No
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Quantitative serum immunoglobulin screening
Yes/No
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index flu shot
Yes/No
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Post-index flu shot
Yes/No
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 diagnosis
Yes/No
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 diagnosis
Yes/No
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 diagnosis and initiation of ofatumumab
Days between COVID-19 diagnosis and initiation of ofatumumab were reported
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 vaccination
Yes/No
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 vaccination
Yes/No
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 vaccination and initiation of ofatumumab
Days between COVID-19 vaccination and initiation of ofatumumab were reported.
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose
E.g. diphenhydramine, dexamethasone and other steroids. pre-medication was defined as medication observed within two days of ofatumumab initiation.
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index HCRU: Number of patients with an inpatient visit
Number of patients with an inpatient visits were reported to report the pre-index healthcare resource utilization
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an ED visit
Number of patients with an ED visit were reported to report the pre-index healthcare resource utilization
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an outpatient visit
Number of patients with an outpatient visit were reported to report the pre-index healthcare resource utilization
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with a pharmacy claim
Number of patients with a pharmacy claim were reported to report the pre-index healthcare resource utilization
Measured: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index HCRU: Number of patients with an inpatient visit
Number of patients with an inpatient visits were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an ED visit
Number of patients with an ED visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an outpatient visit
Number of patients with an outpatient visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with a pharmacy claim
Number of patients with a pharmacy claim were reported to report the post-index healthcare resource utilization accrued while on ofatumumab
Measured: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start3 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 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
- 2,101 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
- NCT05576779
- Sponsor's protocol ID
- COMB157GUS11
- Status last verified
- Nov 2022
- First submitted
- 10 Oct 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
- Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World
- ClinicalTrials.gov ID
- NCT05576779
- Acronym / sponsor ID
- COMB157GUS11
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis,, ofatumumab,, disease-modifying therapy,, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,101 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Oct 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 was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.
Detailed description
The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.
Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.
The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | – | Other: Ofatunumaball eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort |
| Non-ofatumumab | – | –patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prescription claims for ofatumumab or other DMTs of interest.
Key inclusion criteria (3 listed)
- Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.
- -. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
- Patients with linkage to the Dx database.
Key exclusion criteria (1 listed)
- No exclusion criteria were applied to patients in the study.
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 |
|---|---|---|
| OfatunumabAll eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort | Other | Ofatumumab |
Primary outcome
Proportion of patients initiating ofatumumab based on DMT use
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.
34 secondary outcomes
Age
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Gender
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Geographic region
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: State level (Geographic region)
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Insurance type
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Payer
Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Follow-up time
Time frame: Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Number of patients: Pre-index Charlson comorbidity index (CCI)
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index comorbidities
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in inpatient settings
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients with a relapse in outpatient settings
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in all patients
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of relapses in patients with at least 1 relapse
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Claims-Based Disability Score
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of pre-index Brain and Spinal MRI scans
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Hepatitis B virus screening
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Quantitative serum immunoglobulin screening
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Pre-index flu shot
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Number of patients: Post-index flu shot
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 diagnosis
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 diagnosis
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 diagnosis and initiation of ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index: Number of patients with COVID-19 vaccination
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index: Number of patients with COVID-19 vaccination
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Days between COVID-19 vaccination and initiation of ofatumumab
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Pre-index HCRU: Number of patients with an inpatient visit
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an ED visit
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with an outpatient visit
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Pre-index HCRU: Number of patients with a pharmacy claim
Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)
Post-index HCRU: Number of patients with an inpatient visit
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an ED visit
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with an outpatient visit
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
Post-index HCRU: Number of patients with a pharmacy claim
Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)
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 COMB157GUS11 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 3 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 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 initiating ofatumumab based on DMT use (time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)). 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 8 Nov 2026.