Relapsing Multiple SclerosisEAFToSNCT05090033
Characterizing the Use of Ofatumumab in a Real World Setting
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 7 sites in Australia.
Trial summary
This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- ofatumumab
- How many people
- 103 participants
- Where
- 7 sitesAustralia
- Study dates
- 8 Dec 2022to 6 Feb 2026
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Australian patients with multiple sclerosis
Who may be able to join
- Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
- Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
- Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
- Patients will need to provide additional consent to participate in Part II sub-study.
Who cannot join
- Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Concord, New South Wales, 2139
Novartis Investigative Site
Heidelberg, 3084
Novartis Investigative Site
Melbourne, Victoria, 3004
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Southport, Queensland, 4222
Novartis Investigative Site
St Leonards, 2065
About this study
Official title: Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)
This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.
Read the detailed description
This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study.
Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service.
Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study.
The data for the PROs will be collected through a mobile based application .
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- ofatumumab
- Keywords
- ofatumumab, NIS, RMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumabOther
There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Part I study cohort | Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App. Receives: Other: ofatumumab | |
| Part II study cohort | Up to 100 participants responding to PROs via the MSGo Patient App Receives: Other: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I and II: Proportion of doses not completed within three days of the expected date
Proportion of doses not completed within three days of the expected date during initiation to be collected
Measured: Initiation
Part I and II: Proportion of doses not completed within 3 days of the expected date
Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected
Measured: First 3 months of maintenance
Secondary outcomes (19)
Part I: Proportion of doses not completed within three days of the expected date
Proportion of doses not completed within three days of the expected date to be collected
Measured: initiation period plus 12 months of maintenance
Part I: Proportion of doses not completed within 14 days of the expected date
Proportion of doses not completed within 14 days of the expected date to be collected
Measured: 12 months of maintentance
Part I: Proportion of participants with a treatment interruption of more than six months during maintenance
Proportion of participants with a treatment interruption of more than six months during maintenance to be collected.
Interruption is calculated as 6 doses not completed
Measured: Up to 18 months
Part I: Proportion of participants discontinued within three months of the intial dose
Proportion of participants discontinued within three months of the intial dose to be collected
Measured: Up to 18 months
Part I: Proportion of participants discontinued within 12 months of the intial dose.
Proportion of participants discontinued within 12 months of the initial dose to be collected
Measured: Up to 18 months
Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups
Patient sub-groups will be compared to either other complementary sub-groups or the "all patients" cohort
Measured: 12 months
Part II: Proportion of doses not completed within 14 days of the expected date
This outcome measure will be measured for those patients who have MRI completed at approximately 18 months
Measured: during 18 months of maintenance
Part II: proportion of participants discontinued within 18 months of the intial dose
This outcome measure will be measured for those patients who have MRI completed at approximately 18 months
Measured: within 18 months of the initial dose
Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores are expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment.
Measured: Baseline,6 months, 12 months, 18 months
Part II: Change in generic health status as measured by the EQ5D
It comprises of a short descriptive system questionnaire and a visual analogue scale (VAS). The questionnaire provides a simple descriptive profile of a respondents health state and the VAS provides an alternative way to elicit an individuals rating of their own overall current health. Scale is rated from 0 (worst imaginable health) to 100 (the best imaginable scale)
Measured: Baseline, 6 months, 12 months, 18 months
Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).
The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Measured: Baseline, 6 months, 12 months, 18 months
Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)
TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .
Measured: Day 28, 6 months, 12 months, 18 months
Part II: Proportion of self administration
Proportion of self administration as calculated by the number of self administered doses compared to the total number of doses over the total study time
Measured: 18 months
Part II: Proportion of patients initiating ofatumumab who are treatment naïve
Proportion of patients initiating ofatumumab who are treatment naïve relative to prior high efficacy therapy as defined in Australia as alemtuzumab, ocrelizumab, natalizumab and cladribine) and other non-high efficacy Disease Modifying Therapies (DMTs).
Measured: Baseline
Part II: Change in Expanded Disability Status Scale (EDSS)
EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.
EDSS scores range between 0 and 10 in 0.5 unit increments. Scores increase when the severity of the disability increases
Measured: Baseline, 6 months, 12 months
Part II: Annualized relapse rate
Measured by number of relapses over a period of approximately 12 months.
Measured: 12 months
Part II: Number of T1 Gd-enhancing lesions per MRI scan
This will only be assessed where gadolinium is used as per Institution's usual practice. Otherwise, this will not be reported
Measured: Baseline, 6 months, 12 months
Part II: Number of new or enlarging T2 lesions on MRI
Number of new or enlarging T2 lesions on MRI to be collected
Measured: Baseline, 6 months, 12 months
Percentage brain volume change
The percent brain volume change analysis will be performed at 12 months follow up (either Month 12 (cf. Baseline) or Month 18 (cf. Month 6), via use of the SIENA method for atrophy analysis.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start8 Dec 2022
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Prospective
- Enrolment
- 103 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
- NCT05090033
- Sponsor's protocol ID
- COMB157GAU01
- Acronym
- EAFToS
- Status last verified
- Jul 2026
- First submitted
- 22 Sep 2021
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)
- ClinicalTrials.gov ID
- NCT05090033
- Acronym / sponsor ID
- EAFToS / COMB157GAU01
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- ofatumumab, NIS, RMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 22 Oct 2021 (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 is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.
Detailed description
This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study.
Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service.
Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study.
The data for the PROs will be collected through a mobile based application .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I study cohort | – | Other: ofatumumabRetrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App. |
| Part II study cohort | – | Other: ofatumumabUp to 100 participants responding to PROs via the MSGo Patient App |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Australian patients with multiple sclerosis
Key inclusion criteria (4 listed)
- Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
- Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
- Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
- Patients will need to provide additional consent to participate in Part II sub-study.
Key exclusion criteria (1 listed)
- Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
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 |
|---|---|---|
| ofatumumabThere is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled. | Other | Part I study cohort, Part II study cohort |
Primary outcome
Part I and II: Proportion of doses not completed within three days of the expected date
Time frame: Initiation
Proportion of doses not completed within three days of the expected date during initiation to be collected
Part I and II: Proportion of doses not completed within 3 days of the expected date
Time frame: First 3 months of maintenance
Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected
19 secondary outcomes
Part I: Proportion of doses not completed within three days of the expected date
Time frame: initiation period plus 12 months of maintenance
Part I: Proportion of doses not completed within 14 days of the expected date
Time frame: 12 months of maintentance
Part I: Proportion of participants with a treatment interruption of more than six months during maintenance
Time frame: Up to 18 months
Part I: Proportion of participants discontinued within three months of the intial dose
Time frame: Up to 18 months
Part I: Proportion of participants discontinued within 12 months of the intial dose.
Time frame: Up to 18 months
Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups
Time frame: 12 months
Part II: Proportion of doses not completed within 14 days of the expected date
Time frame: during 18 months of maintenance
Part II: proportion of participants discontinued within 18 months of the intial dose
Time frame: within 18 months of the initial dose
Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
Time frame: Baseline,6 months, 12 months, 18 months
Part II: Change in generic health status as measured by the EQ5D
Time frame: Baseline, 6 months, 12 months, 18 months
Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).
Time frame: Baseline, 6 months, 12 months, 18 months
Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)
Time frame: Day 28, 6 months, 12 months, 18 months
Part II: Proportion of self administration
Time frame: 18 months
Part II: Proportion of patients initiating ofatumumab who are treatment naïve
Time frame: Baseline
Part II: Change in Expanded Disability Status Scale (EDSS)
Time frame: Baseline, 6 months, 12 months
Part II: Annualized relapse rate
Time frame: 12 months
Part II: Number of T1 Gd-enhancing lesions per MRI scan
Time frame: Baseline, 6 months, 12 months
Part II: Number of new or enlarging T2 lesions on MRI
Time frame: Baseline, 6 months, 12 months
Percentage brain volume change
Time frame: 12 months follow up
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 31 Jul 2026.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 7 sites in Australia.
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 4 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. 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?
Part I and II: Proportion of doses not completed within three days of the expected date (time frame: Initiation). 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 31 Jul 2026.