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ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients

NCT ID: NCT06345157

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2026-06-30

Brief Summary

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Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.

Detailed Description

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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

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Multiple Sclerosis, Relapsing-Remitting

Keywords

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Multiple Sclerosis, Relapsing-Remitting, RRMS, ofatumumab

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ofatumumab

Patients treated with Ofatumumab

Ofatumumab

Intervention Type DRUG

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.

Interventions

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Ofatumumab

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.

Intervention Type DRUG

Other Intervention Names

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Kesimpta

Eligibility Criteria

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Inclusion Criteria

1. Male or female outpatients ≥18 years old.
2. Patients diagnosed with RRMS (McDonald criteria 2017).
3. 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).
4. Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.

Exclusion Criteria

1. Patients outside the approved label of ofatumumab.
2. Pregnant and lactating women.
3. 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.
4. Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Ancona, AN, Italy

Site Status

Novartis Investigative Site

L’Aquila, AQ, Italy

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Novartis Investigative Site

Bari, BA, Italy

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Novartis Investigative Site

Bergamo, BG, Italy

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Novartis Investigative Site

Chieti, CH, Italy

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Novartis Investigative Site

Catania, CT, Italy

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Novartis Investigative Site

Catanzaro, CZ, Italy

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Novartis Investigative Site

Cona, FE, Italy

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Novartis Investigative Site

Foggia, FG, Italy

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Novartis Investigative Site

Florence, FI, Italy

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Novartis Investigative Site

Genova, GE, Italy

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Novartis Investigative Site

Pozzilli, IS, Italy

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Novartis Investigative Site

Monza, MB, Italy

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Novartis Investigative Site

Palermo, PA, Italy

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Novartis Investigative Site

Pavia, PV, Italy

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Novartis Investigative Site

Ravenna, RA, Italy

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Novartis Investigative Site

Reggio Calabria, RC, Italy

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Novartis Investigative Site

Roma, RM, Italy

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Novartis Investigative Site

Roma, RM, Italy

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Novartis Investigative Site

Roma, RM, Italy

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Novartis Investigative Site

Siena, SI, Italy

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Novartis Investigative Site

Sassari, SS, Italy

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Novartis Investigative Site

Trento, TN, Italy

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Novartis Investigative Site

Orbassano, TO, Italy

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Novartis Investigative Site

Torino, TO, Italy

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Novartis Investigative Site

Treviso, TV, Italy

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Novartis Investigative Site

Udine, UD, Italy

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Novartis Investigative Site

Gallarate, VA, Italy

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Novartis Investigative Site

Vicenza, VI, Italy

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Novartis Investigative Site

Napoli, , Italy

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Novartis Investigative Site

Napoli, , Italy

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Novartis Investigative Site

Novara, , Italy

Site Status

Countries

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Italy

Other Identifiers

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COMB157GIT02

Identifier Type: -

Identifier Source: org_study_id