Clinical trial NCT05090033: Characterizing the Use of Ofatumumab in a Real World Setting
Official title: Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Relapsing Multiple Sclerosis
Keywords: ofatumumab
NIS
RMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Australian patients with multiple sclerosis

Brief summary: This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.

Detailed description: This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study.

Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service.

Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study.

The data for the PROs will be collected through a mobile based application .

Eligibility criteria: Inclusion Criteria:

* Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
* Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
* Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
* Patients will need to provide additional consent to participate in Part II sub-study.

Exclusion Criteria:

* Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information\].

Primary outcomes:
measure: Part I and II: Proportion of doses not completed within three days of the expected date
timeFrame: Initiation
measure: Part I and II: Proportion of doses not completed within 3 days of the expected date
timeFrame: First 3 months of maintenance
Secondary outcomes:
measure: Part I: Proportion of doses not completed within three days of the expected date
timeFrame: initiation period plus 12 months of maintenance
measure: Part I: Proportion of doses not completed within 14 days of the expected date
timeFrame: 12 months of maintentance
measure: Part I: Proportion of participants with a treatment interruption of more than six months during maintenance
timeFrame: Up to 18 months
measure: Part I: Proportion of participants discontinued within three months of the intial dose
timeFrame: Up to 18 months
measure: Part I: Proportion of participants discontinued within 12 months of the intial dose.
timeFrame: Up to 18 months
measure: Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups
timeFrame: 12 months
measure: Part II: Proportion of doses not completed within 14 days of the expected date
timeFrame: during 18 months of maintenance
measure: Part II: proportion of participants discontinued within 18 months of the intial dose
timeFrame: within 18 months of the initial dose
measure: Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: Baseline,6 months, 12 months, 18 months
measure: Part II: Change in generic health status as measured by the EQ5D
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)
timeFrame: Day 28, 6 months, 12 months, 18 months
measure: Part II: Proportion of self administration
timeFrame: 18 months
measure: Part II: Proportion of patients initiating ofatumumab who are treatment naïve
timeFrame: Baseline
measure: Part II: Change in Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, 6 months, 12 months
measure: Part II: Annualized relapse rate
timeFrame: 12 months
measure: Part II: Number of T1 Gd-enhancing lesions per MRI scan
timeFrame: Baseline, 6 months, 12 months
measure: Part II: Number of new or enlarging T2 lesions on MRI
timeFrame: Baseline, 6 months, 12 months
measure: Percentage brain volume change
timeFrame: 12 months follow up
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Southport
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
city: St Leonards
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: