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

NCT06345157

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Ofatumumab

Countries: Italy

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

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (31)
  • Ancona, AN, Italy
  • L’Aquila, AQ, Italy
  • Bari, BA, Italy
  • Bergamo, BG, Italy
  • Chieti, CH, Italy
  • Catania, CT, Italy
  • Catanzaro, CZ, Italy
  • Cona, FE, Italy
  • Foggia, FG, Italy
  • Florence, FI, Italy
  • Genova, GE, Italy
  • Pozzilli, IS, Italy
  • Monza, MB, Italy
  • Palermo, PA, Italy
  • Pavia, PV, Italy
  • Ravenna, RA, Italy
  • Reggio Calabria, RC, Italy
  • Roma, RM, Italy
  • Roma, RM, Italy
  • Siena, SI, Italy
  • Sassari, SS, Italy
  • Trento, TN, Italy
  • Orbassano, TO, Italy
  • Torino, TO, Italy
  • Treviso, TV, Italy
  • Udine, UD, Italy
  • Gallarate, VA, Italy
  • Vicenza, VI, Italy
  • Naples, Italy
  • Naples, Italy
  • + 1 more on CT.gov