Relapsing Multiple SclerosisNCT05809986
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 10 sites in Portugal.
Trial summary
This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ofatumumab
- How many people
- 174 participants
- Where
- 10 sitesPortugal
- Study dates
- 27 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and with Ofatumumab treatment in line with the Portuguese label i.e., adult patients with active, relapsing forms of MS.
Who may be able to join
- To participate in the study, all the following inclusion criteria must be met:
- Patients aged 18 years or older
- Written informed consent obtained before participating in the study.
- Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).
- Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
Who cannot join
- To participate in the study, none of the following exclusion criteria must be met:
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
10 sites in 1 country
Portugal10 sites, 10 recruiting
- Recruiting
Novartis Investigative Site
Amadora, 2720-276
- Recruiting
Novartis Investigative Site
Guimarães, 4835-044
- Recruiting
Novartis Investigative Site
Leiria, 2410-197
- Recruiting
Novartis Investigative Site
Lisbon, 1169-050
- Recruiting
Novartis Investigative Site
Lisbon, 1349-019
- Recruiting
Novartis Investigative Site
Lisbon, 1649-035
- Recruiting
Novartis Investigative Site
Matosinhos Municipality, 4454-513
- Recruiting
Novartis Investigative Site
Ponte de Lima, 4990-041
- Recruiting
Novartis Investigative Site
Porto, 4200 319
- Recruiting
Novartis Investigative Site
Setúbal, 2910-549
About this study
This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.
Read the detailed description
This is a 2 cohort, multi-center, observational study carried out in Portugal that aims to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and later in their disease (cohorts 1 and 2, respectively).
Data will be collected during 3 visits distributed over a maximum period of 24 months. Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation.
The study includes patients that have initiated Ofatumumab up to 12 months prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
Patients in both cohorts will have to be treated with Ofatumumab for at least two years to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ofatumumab
- Keywords
- Relapsing Multiple Sclerosis, RMS, Ofatumumab, NIS, Portugal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabOther
Also called Kesimpta
There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Early treatment arm | All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch). Receives: Other: Ofatumumab | |
| Cohort 2: Late treatment arm | All patients who initiated Ofatumumab with more than 3 years of MS diagnosis. Receives: Other: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients demonstrating NEDA-3
Proportion of patients demonstrating No Evidence of Disease Activity (NEDA)-3 (12-24 months) in both cohorts, respectively. NEDA-3 is defined by no confirmed Multiple Sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
Measured: from month 12 up to month 24
Secondary outcomes (6)
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3 (12-24 months) in the overall population and in both cohorts.
Measured: 12-24 months
Multiple Sclerosis Impact Scale Questionnaire (MSIS-29)
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29 (baseline, 12 and 24 months) in the overall population and in both cohorts.
MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options. Each score domain is obtained by summing all individual items and transformed it to a -100 scale where high scores indicate worse health.
Measured: Baseline, Month 12, Month 24
Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by FSIQ-RMS (baseline, 12 and 24 months) in the overall population and in both cohorts.
The FSIQ-RMS is a patient-reported outcome (PRO) instrument used to assess fatigue in patients with relapsing types of multiple sclerosis (RMS).It is a 20-item self-report measure with 7 items for MS-related symptoms of fatigue and 13 for fatigue-related impacts on several aspects of patients' lives. The impact of fatigue divides into 3 subdomains: physical, cognitive and emotional, and coping. The scores for fatigue and the subdomains of impact are standardized to a 0-100 scale using a scoring algorithm, with higher scores indicating more severe symptoms and impacts.
Measured: Baseline, Month 12, Month 24
Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9)
Treatment satisfaction with Ofatumumab as measured by TSQM-9 (baseline, 12 and 24 months) in the overall population and in both cohorts.
The TSQM-9 is a validated tool, widely used, to measure treatment satisfaction that will be applied in the context of this study regarding Ofatumumab. The TSQM-9 uses nine of the 14 TSQM Version 1.4 items, not including five questions related to side effects of medication, and comprises three scales: the effectiveness scale, the convenience scale and the global scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
Measured: Month 12, Month 24
Proportion of patients permanently discontinuing Ofatumumab during the study
Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation in the overall population and in both cohorts
Measured: up to month 24
Proportion of patients demonstrating NEDA-3 in the overall population.
Proportion of patients demonstrating NEDA-3 in the overall population.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start27 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- 174 participants (estimated)
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
- NCT05809986
- Sponsor's protocol ID
- COMB157GPT04
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
- ClinicalTrials.gov ID
- NCT05809986
- Acronym / sponsor ID
- COMB157GPT04
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis, RMS, Ofatumumab, NIS, Portugal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2023 (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 non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.
Detailed description
This is a 2 cohort, multi-center, observational study carried out in Portugal that aims to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and later in their disease (cohorts 1 and 2, respectively).
Data will be collected during 3 visits distributed over a maximum period of 24 months. Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation.
The study includes patients that have initiated Ofatumumab up to 12 months prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
Patients in both cohorts will have to be treated with Ofatumumab for at least two years to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Early treatment arm | – | Other: OfatumumabAll patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch). |
| Cohort 2: Late treatment arm | – | Other: OfatumumabAll patients who initiated Ofatumumab with more than 3 years of MS diagnosis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and with Ofatumumab treatment in line with the Portuguese label i.e., adult patients with active, relapsing forms of MS.
Key inclusion criteria (7 listed)
- Patients aged 18 years or older
- Written informed consent obtained before participating in the study.
- Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).
Key exclusion criteria (3 listed)
- Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
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 |
|---|---|---|
| OfatumumabAlso: KesimptaThere is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis | Other | Cohort 1: Early treatment arm, Cohort 2: Late treatment arm |
Primary outcome
Proportion of patients demonstrating NEDA-3
Time frame: from month 12 up to month 24
Proportion of patients demonstrating No Evidence of Disease Activity (NEDA)-3 (12-24 months) in both cohorts, respectively. NEDA-3 is defined by no confirmed Multiple Sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
6 secondary outcomes
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Time frame: 12-24 months
Multiple Sclerosis Impact Scale Questionnaire (MSIS-29)
Time frame: Baseline, Month 12, Month 24
Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)
Time frame: Baseline, Month 12, Month 24
Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9)
Time frame: Month 12, Month 24
Proportion of patients permanently discontinuing Ofatumumab during the study
Time frame: up to month 24
Proportion of patients demonstrating NEDA-3 in the overall population.
Time frame: 12-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 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 10 sites in Portugal.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 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 10 sites in Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients demonstrating NEDA-3 (time frame: from month 12 up to month 24). 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 7 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.