Multiple Sclerosis, Relapsing-RemittingNCT06345157
ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 31 sites in Italy.
Trial summary
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Ofatumumab
- How many people
- 379 participants
- Where
- 31 sitesItaly
- Study dates
- 30 Jul 2024to 30 Jun 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: 300 RRMS patients newly treated with ofatumumab.
Who may be able to join
- Male or female outpatients ≥18 years old.
- Patients diagnosed with RRMS (McDonald criteria 2017).
- Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
- Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.
Who cannot join
- Patients outside the approved label of ofatumumab.
- Pregnant and lactating women.
- Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
- Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
- Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Italy31 sites
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Catanzaro, CZ, 88100
Novartis Investigative Site
Chieti, CH, 66100
Novartis Investigative Site
Cona, FE, 44124
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Foggia, FG, 71122
Novartis Investigative Site
Gallarate, VA, 21013
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
L’Aquila, AQ, 67100
Novartis Investigative Site
Monza, MB, 20900
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Pozzilli, IS, 86077
Novartis Investigative Site
Ravenna, RA, 48100
Novartis Investigative Site
Reggio Calabria, RC, 89124
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Torino, TO, 10126
Novartis Investigative Site
Trento, TN, 38122
Novartis Investigative Site
Treviso, TV, 31100
Novartis Investigative Site
Udine, UD, 33100
Novartis Investigative Site
Vicenza, VI, 36100
About this study
Official title: An ITAlian Observational, Multicenter, 12-month, Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab (Kesimpta®) in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
Read the detailed description
Prospective real-world data on ofatumumab is still very limited. For this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life.
This is an observational, multicenter, single-arm, prospective study. Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Ofatumumab
- Keywords
- Multiple Sclerosis,, Relapsing-Remitting,, RRMS,, ofatumumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called Kesimpta
This is an observational study. There is no treatment allocation. The decision to initiate treatment with ofatumumab (Kesimpta®) will be based solely on clinical judgement and according to the SmPC and AIFA reimbursement criteria.
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Patients treated with Ofatumumab Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate (ARR)
Annualized relapse rate (ARR) after a maximum observation period of 12 months of ofatumumab treatment.
ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
Measured: 1 year
Secondary outcomes (8)
Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)
To evaluate absolute and relative frequencies of patients with an improvement in SDMT (Symbol Digit Modality Test). An improvement is defined as an increase in the score of 4 or more points from baseline.
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance.
Measured: Baseline, month 6, month 12
Fatigue Severity Scale [FSS]
Proportion of patients passing from "fatigued" (F) to "not fatigued" (NF), according to the Fatigue Severity Scale [FSS].
FSS is a 9-statement interview with a 7-point scale response per statement, with higher scores indicating more fatigue. Patients with a mean FSS score ≥ 4 are considered fatigued (F), while those with a mean FSS score < 4 not fatigued (NF).
Measured: Baseline, month 3, month 6 and month 12
Quality of life parameters assessed by EQ-5D-3L
EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
Measured: Baseline, 12 months
Treatment satisfaction assessed by TSQM-9
Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9). 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 6, month 12
Expanded Disability Status Scale (EDSS)
Proportion of patients with an improved, stable or worsened EDSS. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of ≥2 to 6 or ≥6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of ≤1 or ≤0.5, respectively For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively.
Measured: Baseline, month 12 months
Variation of NfL in plasma
Variation of Neurofilaments (NfL) in plasma of the patients
Measured: Baseline, month 6 and month 12
Adverse Events (AEs)
Exposure-adjusted proportion of patients with adverse events (AE) or serious adverse events (SAE) per 100 subject-years.
Measured: 12 months
Discontinuation rates due to AE and/or other reasons
Discontinuation rates due to AE and/or other reasons
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345157
- Sponsor's protocol ID
- COMB157GIT02
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ITAlian Observational, Multicenter, 12-month, Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab (Kesimpta®) in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study
- ClinicalTrials.gov ID
- NCT06345157
- Acronym / sponsor ID
- COMB157GIT02
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis,, Relapsing-Remitting,, RRMS,, ofatumumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Apr 2024 (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.
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
Detailed description
Prospective real-world data on ofatumumab is still very limited. For this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life.
This is an observational, multicenter, single-arm, prospective study. Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | – | Drug: OfatumumabPatients treated with Ofatumumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 RRMS patients newly treated with ofatumumab.
Key inclusion criteria (4 listed)
- Male or female outpatients ≥18 years old.
- Patients diagnosed with RRMS (McDonald criteria 2017).
- Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
- Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.
Key exclusion criteria (5 listed)
- Patients outside the approved label of ofatumumab.
- Pregnant and lactating women.
- Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
- Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
- Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
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: KesimptaThis is an observational study. There is no treatment allocation. The decision to initiate treatment with ofatumumab (Kesimpta®) will be based solely on clinical judgement and according to the SmPC and AIFA reimbursement criteria. | Drug | Ofatumumab |
Primary outcome
Annualized relapse rate (ARR)
Time frame: 1 year
Annualized relapse rate (ARR) after a maximum observation period of 12 months of ofatumumab treatment. ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
8 secondary outcomes
Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)
Time frame: Baseline, month 6, month 12
Fatigue Severity Scale [FSS]
Time frame: Baseline, month 3, month 6 and month 12
Quality of life parameters assessed by EQ-5D-3L
Time frame: Baseline, 12 months
Treatment satisfaction assessed by TSQM-9
Time frame: Month 6, month 12
Expanded Disability Status Scale (EDSS)
Time frame: Baseline, month 12 months
Variation of NfL in plasma
Time frame: Baseline, month 6 and month 12
Adverse Events (AEs)
Time frame: 12 months
Discontinuation rates due to AE and/or other reasons
Time frame: 12 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 13 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites 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 31 sites in Italy.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized relapse rate (ARR) (time frame: 1 year). 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 13 Apr 2026.