Multiple Sclerosis, Relapsing-RemittingNCT06897657
A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 25 Jul 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, non-interventional cohort study.
Who may be able to join
- Patients were included in the study if they met all of the following criteria:
- Patient was prescribed ofatumumab within the UK approved marketing authorization
- Patient initiated ofatumumab via participating MS clinic with or without KC PSP
- Patients initiated ofatumumab during the index identification window
- Authorized to collect study data:
- Patient was alive at start of data collection and patient consented prior to start of their data collection or,
Show all 9Show fewer
- Patient was deceased at start of data collection and a member of the patient's direct care team had a pre-existing right to access patient medical record
- Specifically for adherence analyses: Patients were required to have a minimum of 6 months of follow-up post index date available to make this assessment
- Specifically for clinical effectiveness analyses: Patients were required to have a minimum of 6 months look-back pre-index date and minimum 6 months follow-up post index date available to make this assessment.
Who cannot join
- Patients were excluded from the study if they met the following criteria:
- Patient prescribed ofatumumab outside the approved marketing authorization (i.e., under off-label prescribing) at any point within the patients record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective, Non-interventional Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with National Health Service (NHS) databases and/or homecare and pharmacy services prescribing ofatumumab were identified and recruited for study participation using a feasibility assessment exercise. The study index identification window spanned from 26 March 2021 to 30 June 2023 (or latest data available prior to start of study data extraction). The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window. From index date, patients were followed up until death, up to 13 months after index date, loss to follow-up, or end of study index identification window (whichever came first).
For patients who consented to the use of their data, participating sites transcribed protocol required patient data from existing individual patient medical records into an electronic case report form (eCRF). The end of study was defined as the date of last data query resolution (i.e., all data had been recorded in the eCRF and all data queries resolved to allow database lock to occur). This ensured that all data was available to answer the research questions in the study.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Disease modifying therapy, Medication adherence, Ofatumumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Medication Adherence
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 |
|---|---|---|
| Overall MS Cohort | Adult patients with relapsing-remitting multiple sclerosis (RMS) who were prescribed ofatumumab from either an MS clinic participating in the Kesimpta Connect (KC) patient support program (PSP) or an MS clinic not participating in the KC PSP. | |
| KC PSP User Cohort | Adult patients with RMS who were prescribed ofatumumab from an MS clinic participating in the KC PSP. | |
| Non-KC PSP User Cohort | Adult patients with RMS who were prescribed ofatumumab from an MS clinic not participating in the KC PSP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Possession Ratio (MPR)
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period.
Measured: Up to 13 months
Number of Patients by MPR Category
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Secondary outcomes (29)
Number of Patients by Demographic Category
Demographic categories included:
- Age group
- Gender
- Ethnicity
- Socioeconomic status (most deprived to least deprived)
- Decade of MS diagnosis
- Prior disease modifying treatment (DMT) treatment status (treatment naïve or received prior DMT)
Measured: Baseline
Time From MS Diagnosis to Ofatumumab Initiation
Measured: Baseline
Number of Patients by Comorbidity
Measured: Baseline
Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation
Measured: Up to 13 months
Number of Prior DMTs Reported
Measured: Up to 13 months
Number of Patients by Prior DMT Category
DMT categories included:
- Type of prior DMT
- Efficacy of DMT (moderate efficacy, more effective, high efficacy)
- Use of injectable DMT
- Type of injectable DMT
Measured: Up to 13 months
Number of Patients by Reason for Switch from Other DMT to Ofatumumab
Measured: Up to 13 months
Individual Annualized Relapse Rate (ARR) Before Ofatumumab Initiation
Individual ARR was derived per patient as [(number of confirmed MS relapses) / (time at risk (years)].
Measured: Up to 13 months
Total ARR Before Ofatumumab Initiation
Total ARR was derived as [(total number of confirmed MS relapses) / (total number of person-years at risk)].
Measured: Up to 13 months
Individual ARR After Ofatumumab Initiation
Individual ARR was derived per patient as [(number of confirmed MS relapses) / (time at risk (years)].
Measured: Up to 13 months
Total ARR After Ofatumumab Initiation
Total ARR was derived as [(total number of confirmed MS relapses) / (total number of person-years at risk)].
Measured: Up to 13 months
Average Expanded Disability Status Scale (EDSS) Score Before Ofatumumab Initiation
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
Measured: Up to 13 months
Average EDSS Score After Ofatumumab Initiation
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
Measured: Up to 13 months
Absolute Change in Average EDSS Score
Absolute change in average EDSS score between 2 study periods was derived as: [mean EDSS score during the follow-up period] - [mean EDSS score during the pre-index period]. The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window.
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
Measured: Up to 26 months
Average Number of T1 and T2 Lesions Before Ofatumumab Initiation
Measured: Up to 13 months
Average Number of T1 and T2 Lesions After Ofatumumab Initiation
Measured: Up to 13 months
Individual ARR After Ofatumumab Initiation by MPR Category
Individual ARR was derived per patient as [(number of confirmed MS relapses) / (time at risk (years)].
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Total ARR After Ofatumumab Initiation by MPR Category
Total ARR was derived as [(total number of confirmed MS relapses) / (total number of person-years at risk)].
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Average EDSS Score Before Ofatumumab Initiation by MPR Category
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Average EDSS Score After Ofatumumab Initiation by MPR Category
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score is determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Absolute Change in Average EDSS Score by MPR Category
Absolute change in average EDSS score between 2 study periods was derived as: [mean EDSS score during the follow-up period] - [mean EDSS score during the pre-index period]. The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window.
The EDSS is a tool used to measure how much a person is affected by their MS. It consists of 8 functional systems (FS): Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the patients score was determined between 0 (normal) and 10 (death due to MS).
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 26 months
Number of Patients per MPR Category by Type of KC PSP Services Received
KC PSP services included face-to-face nurse visits, virtual nurse visits, and mobile text reminders.
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories:
- High MPR: MPR = 1.0
- Intermediate MPR: 0.8 ≤ MPR <1.0
- Low MPR: MPR <0.8.
Measured: Up to 13 months
Number of Medical Visits After Ofatumumab Initiation
Medical visits included accident and emergency (A\&E) visits, inpatient visits, and outpatient visits.
Measured: Up to 13 months
Annualized Medical Visit Rate After Ofatumumab Initiation
Annualized medical visit rate per patient was calculated as [(number of events during follow-up period) / (time at risk (years) during follow-up period)]. Rates were calculated for the following types of medical visits: A\&E visits, inpatient visits, and outpatient visits.
Measured: Up to 13 months
Number of MS-related Medical Visits After Ofatumumab Initiation
MS-related medical visits included A\&E visits, inpatient visits, and outpatient visits.
Measured: Up to 13 months
Annualized MS-related Medical Visit Rate After Ofatumumab Initiation
Annualized MS-related medical visit rate per patient was calculated as [(number of events during follow-up period) / (time at risk (years) during follow-up period)]. Rates were calculated for the following types of MS-related medical visits: A\&E visits, inpatient visits, and outpatient visits.
Measured: Up to 13 months
Number of Patients With Medically Reported Adherence (MRA) After Ofatumumab Initiation
Full adherence was defined as no record of dose/s missed between ofatumumab initiation and the point at which the patient was censored. Partial adherence was defined as a record of at least one dose missed between ofatumumab initiation and the point at which the patient was censored. The date of censoring was defined as the earliest of the following:
- End of the study follow-up (13 months)
- Death
- Lost to follow-up
- End of study index identification period
Measured: Up to 13 months
Number of Patients by Reason for Discontinuation of Ofatumumab
Measured: Up to 13 months
Number of Patients who Switched From Ofatumumab to an Alternative DMT
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start6 Nov 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 155 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
- NCT06897657
- Sponsor's protocol ID
- COMB157GGB01
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Non-interventional Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
- ClinicalTrials.gov ID
- NCT06897657
- Acronym / sponsor ID
- COMB157GGB01
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Disease modifying therapy, Medication adherence, Ofatumumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 27 Mar 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 was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with National Health Service (NHS) databases and/or homecare and pharmacy services prescribing ofatumumab were identified and recruited for study participation using a feasibility assessment exercise. The study index identification window spanned from 26 March 2021 to 30 June 2023 (or latest data available prior to start of study data extraction). The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window. From index date, patients were followed up until death, up to 13 months after index date, loss to follow-up, or end of study index identification window (whichever came first).
For patients who consented to the use of their data, participating sites transcribed protocol required patient data from existing individual patient medical records into an electronic case report form (eCRF). The end of study was defined as the date of last data query resolution (i.e., all data had been recorded in the eCRF and all data queries resolved to allow database lock to occur). This ensured that all data was available to answer the research questions in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall MS Cohort | – | –Adult patients with relapsing-remitting multiple sclerosis (RMS) who were prescribed ofatumumab from either an MS clinic participating in the Kesimpta Connect (KC) patient support program (PSP) or an MS clinic not participating in the KC PSP. |
| KC PSP User Cohort | – | –Adult patients with RMS who were prescribed ofatumumab from an MS clinic participating in the KC PSP. |
| Non-KC PSP User Cohort | – | –Adult patients with RMS who were prescribed ofatumumab from an MS clinic not participating in the KC PSP. |
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, non-interventional cohort study.
Key inclusion criteria (9 listed)
- Patient was prescribed ofatumumab within the UK approved marketing authorization
- Patient initiated ofatumumab via participating MS clinic with or without KC PSP
- Patients initiated ofatumumab during the index identification window
- Authorized to collect study data:
- Specifically for adherence analyses: Patients were required to have a minimum of 6 months of follow-up post index date available to make this assessment
Key exclusion criteria (2 listed)
- Patient prescribed ofatumumab outside the approved marketing authorization (i.e., under off-label prescribing) at any point within the patients record
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
Medical Possession Ratio (MPR)
Time frame: Up to 13 months
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period.
Number of Patients by MPR Category
Time frame: Up to 13 months
MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories: * High MPR: MPR = 1.0 * Intermediate MPR: 0.8 ≤ MPR <1.0 * Low MPR: MPR <0.8.
29 secondary outcomes
Number of Patients by Demographic Category
Time frame: Baseline
Time From MS Diagnosis to Ofatumumab Initiation
Time frame: Baseline
Number of Patients by Comorbidity
Time frame: Baseline
Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation
Time frame: Up to 13 months
Number of Prior DMTs Reported
Time frame: Up to 13 months
Number of Patients by Prior DMT Category
Time frame: Up to 13 months
Number of Patients by Reason for Switch from Other DMT to Ofatumumab
Time frame: Up to 13 months
Individual Annualized Relapse Rate (ARR) Before Ofatumumab Initiation
Time frame: Up to 13 months
Total ARR Before Ofatumumab Initiation
Time frame: Up to 13 months
Individual ARR After Ofatumumab Initiation
Time frame: Up to 13 months
Total ARR After Ofatumumab Initiation
Time frame: Up to 13 months
Average Expanded Disability Status Scale (EDSS) Score Before Ofatumumab Initiation
Time frame: Up to 13 months
Average EDSS Score After Ofatumumab Initiation
Time frame: Up to 13 months
Absolute Change in Average EDSS Score
Time frame: Up to 26 months
Average Number of T1 and T2 Lesions Before Ofatumumab Initiation
Time frame: Up to 13 months
Average Number of T1 and T2 Lesions After Ofatumumab Initiation
Time frame: Up to 13 months
Individual ARR After Ofatumumab Initiation by MPR Category
Time frame: Up to 13 months
Total ARR After Ofatumumab Initiation by MPR Category
Time frame: Up to 13 months
Average EDSS Score Before Ofatumumab Initiation by MPR Category
Time frame: Up to 13 months
Average EDSS Score After Ofatumumab Initiation by MPR Category
Time frame: Up to 13 months
Absolute Change in Average EDSS Score by MPR Category
Time frame: Up to 26 months
Number of Patients per MPR Category by Type of KC PSP Services Received
Time frame: Up to 13 months
Number of Medical Visits After Ofatumumab Initiation
Time frame: Up to 13 months
Annualized Medical Visit Rate After Ofatumumab Initiation
Time frame: Up to 13 months
Number of MS-related Medical Visits After Ofatumumab Initiation
Time frame: Up to 13 months
Annualized MS-related Medical Visit Rate After Ofatumumab Initiation
Time frame: Up to 13 months
Number of Patients With Medically Reported Adherence (MRA) After Ofatumumab Initiation
Time frame: Up to 13 months
Number of Patients by Reason for Discontinuation of Ofatumumab
Time frame: Up to 13 months
Number of Patients who Switched From Ofatumumab to an Alternative DMT
Time frame: Up to 13 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 27 Mar 2025.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
RecruitingObservational study
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
Relapse Remitting Multiple Sclerosis
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, Relapsing-Remitting, 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 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 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?
Medical Possession Ratio (MPR) (time frame: Up to 13 months). 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 27 Mar 2025.