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NCT06345157Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
379 (actual)
First submitted
27 Mar 2024
Start date
30 Jul 2024
Primary completion date
30 Jun 2026
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06345157

What you commit to

  • Study type: Observational
  • Participants enrolled: 379
  • From 30 Jul 2024 to the primary completion date, 30 Jun 2026
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.

Other illness

  • 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.

Other

  • Patients outside the approved label of ofatumumab.
  • Pregnant and lactating women.
  • Patients cannot participate in this non-interventional study if they also participate in an interventional trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
Coordinator of this site? Confirm its status
AnconaItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
BariItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
BergamoItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
CataniaItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
CatanzaroItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ChietiItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ConaItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
FoggiaItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
GallarateItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
GenovaItalyUnknown status
Novartis Investigative Site
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L’AquilaItalyUnknown status
Novartis Investigative Site
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MonzaItalyUnknown status
Novartis Investigative Site
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NaplesItalyUnknown status
Novartis Investigative Site
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NovaraItalyUnknown status
Novartis Investigative Site
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OrbassanoItalyUnknown status
Novartis Investigative Site
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PalermoItalyUnknown status
Novartis Investigative Site
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PaviaItalyUnknown status
Novartis Investigative Site
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PozzilliItalyUnknown status
Novartis Investigative Site
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RavennaItalyUnknown status
Novartis Investigative Site
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Reggio CalabriaItalyUnknown status
Novartis Investigative Site
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RomaItalyUnknown status
Novartis Investigative Site
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SassariItalyUnknown status
Novartis Investigative Site
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SienaItalyUnknown status
Novartis Investigative Site
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TorinoItalyUnknown status
Novartis Investigative Site
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TrentoItalyUnknown status
Novartis Investigative Site
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TrevisoItalyUnknown status
Novartis Investigative Site
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UdineItalyUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
VicenzaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.