Active — Not RecruitingNot Applicable

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

Italy379 participantsStarted 2024-07-30

Plain-language summary

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

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Annualized relapse rate (ARR)

Timeframe: 1 year

NCT IDNCT06345157

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30