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
- Diseases
- Multiple sclerosis
- 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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Gallarate | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Pozzilli | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Trento | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Treviso | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.