Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
ConditionRelapsing Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older
Written informed consent obtained before participating in the study.
Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
Disqualifiers
Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
Trial population
The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and with Ofatumumab treatment in line with the Portuguese label i.e., adult patients with active, relapsing forms of MS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ofatumumab
Other interventionThere is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Early treatment arm1 intervention
Group B: Cohort 2: Late treatment arm1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients demonstrating NEDA-3
Proportion of patients demonstrating No Evidence of Disease Activity (NEDA)-3 (12-24 months) in both cohorts, respectively. NEDA-3 is defined by no confirmed Multiple Sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
Time frame
from month 12 up to month 24Secondary outcomes
1
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3 (12-24 months) in the overall population and in both cohorts.
Time frame
12-24 months2
Multiple Sclerosis Impact Scale Questionnaire (MSIS-29)
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29 (baseline, 12 and 24 months) in the overall population and in both cohorts. MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options. Each score domain is obtained by summing all individual items and transformed it to a -100 scale where high scores indicate worse health.
Time frame
Baseline, Month 12, Month 243
Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by FSIQ-RMS (baseline, 12 and 24 months) in the overall population and in both cohorts. The FSIQ-RMS is a patient-reported outcome (PRO) instrument used to assess fatigue in patients with relapsing types of multiple sclerosis (RMS).It is a 20-item self-report measure with 7 items for MS-related symptoms of fatigue and 13 for fatigue-related impacts on several aspects of patients' lives. The impact of fatigue divides into 3 subdomains: physical, cognitive and emotional, and coping. The scores for fatigue and the subdomains of impact are standardized to a 0-100 scale using a scoring algorithm, with higher scores indicating more severe symptoms and impacts.
Time frame
Baseline, Month 12, Month 244
Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9)
Treatment satisfaction with Ofatumumab as measured by TSQM-9 (baseline, 12 and 24 months) in the overall population and in both cohorts. The TSQM-9 is a validated tool, widely used, to measure treatment satisfaction that will be applied in the context of this study regarding Ofatumumab. The TSQM-9 uses nine of the 14 TSQM Version 1.4 items, not including five questions related to side effects of medication, and comprises three scales: the effectiveness scale, the convenience scale and the global scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
Time frame
Month 12, Month 24Sponsors and contacts
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Source ClinicalTrials.gov