Running, not recruitingRelapsing MSNCT06345157

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Annualized relapse rate (ARR)

    1 year

    Relapses

Other measures (8)

  • Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)

    Baseline, month 6, month 12

    Thinking and memory
  • Fatigue Severity Scale [FSS]

    Baseline, month 3, month 6 and month 12

    Fatigue
  • Quality of life parameters assessed by EQ-5D-3L

    Baseline, 12 months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Treatment satisfaction assessed by TSQM-9

    Month 6, month 12

    Quality of life (reported by participants)Safety
  • Expanded Disability Status Scale (EDSS)

    Baseline, month 12 months

    Disability progression
  • Variation of NfL in plasma

    Baseline, month 6 and month 12

    Blood or spinal fluid markers
  • Adverse Events (AEs)

    12 months

    Safety
  • Discontinuation rates due to AE and/or other reasons

    12 months

Who could take part

Relapsing MS · 18 to 99

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jul 2024

    2. Main results due

      Jun 2026

    3. Finished

      Jun 2026

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error