Characterizing the Use of Ofatumumab in a Real World Setting

Relapsing Multiple Sclerosis Clinical Trial

— EAFToS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090033
• Other study ID #: COMB157GAU01
• Status: Recruiting
• Start date: December 8, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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].

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis

Intervention

Other:
• ofatumumab
There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Concord	New South Wales
Australia	Novartis Investigative Site	Heidelberg
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	Southport	Queensland
Australia	Novartis Investigative Site	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part I and II: Proportion of doses not completed within three days of the expected date	Proportion of doses not completed within three days of the expected date during initiation to be collected	Initiation
Primary	Part I and II: Proportion of doses not completed within 3 days of the expected date	Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected	First 3 months of maintenance
Secondary	Part I: Proportion of doses not completed within three days of the expected date	Proportion of doses not completed within three days of the expected date to be collected	initiation period plus 12 months of maintenance
Secondary	Part I: Proportion of doses not completed within 14 days of the expected date	Proportion of doses not completed within 14 days of the expected date to be collected	12 months of maintentance
Secondary	Part I: Proportion of participants with a treatment interruption of more than six months during maintenance	Proportion of participants with a treatment interruption of more than six months during maintenance to be collected.; Interruption is calculated as 6 doses not completed	Up to 18 months
Secondary	Part I: Proportion of participants discontinued within three months of the intial dose	Proportion of participants discontinued within three months of the intial dose to be collected	Up to 18 months
Secondary	Part I: Proportion of participants discontinued within 12 months of the intial dose.	Proportion of participants discontinued within 12 months of the initial dose to be collected	Up to 18 months
Secondary	Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups	Patient sub-groups will be compared to either other complementary sub-groups or the "all patients" cohort	12 months
Secondary	Part II: Proportion of doses not completed within 14 days of the expected date	This outcome measure will be measured for those patients who have MRI completed at approximately 18 months	during 18 months of maintenance
Secondary	Part II: proportion of participants discontinued within 18 months of the intial dose	This outcome measure will be measured for those patients who have MRI completed at approximately 18 months	within 18 months of the initial dose
Secondary	Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire	The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores are expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment.	Baseline,6 months, 12 months, 18 months
Secondary	Part II: Change in generic health status as measured by the EQ5D	It comprises of a short descriptive system questionnaire and a visual analogue scale (VAS). The questionnaire provides a simple descriptive profile of a respondents health state and the VAS provides an alternative way to elicit an individuals rating of their own overall current health. Scale is rated from 0 (worst imaginable health) to 100 (the best imaginable scale)	Baseline, 6 months, 12 months, 18 months
Secondary	Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).	The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).	Baseline, 6 months, 12 months, 18 months
Secondary	Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)	TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .	Day 28, 6 months, 12 months, 18 months
Secondary	Part II: Proportion of self administration	Proportion of self administration as calculated by the number of self administered doses compared to the total number of doses over the total study time	18 months
Secondary	Part II: Proportion of patients initiating ofatumumab who are treatment naïve	Proportion of patients initiating ofatumumab who are treatment naïve relative to prior high efficacy therapy as defined in Australia as alemtuzumab, ocrelizumab, natalizumab and cladribine) and other non-high efficacy Disease Modifying Therapies (DMTs).	Baseline
Secondary	Part II: Change in Expanded Disability Status Scale (EDSS)	EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.; EDSS scores range between 0 and 10 in 0.5 unit increments. Scores increase when the severity of the disability increases	Baseline, 6 months, 12 months
Secondary	Part II: Annualized relapse rate	Measured by number of relapses over a period of approximately 12 months.	12 months
Secondary	Part II: Number of T1 Gd-enhancing lesions per MRI scan	This will only be assessed where gadolinium is used as per Institution's usual practice. Otherwise, this will not be reported	Baseline, 6 months, 12 months
Secondary	Part II: Number of new or enlarging T2 lesions on MRI	Number of new or enlarging T2 lesions on MRI to be collected	Baseline, 6 months, 12 months
Secondary	Percentage brain volume change	The percent brain volume change analysis will be performed at 12 months follow up (either Month 12 (cf. Baseline) or Month 18 (cf. Month 6), via use of the SIENA method for atrophy analysis.	12 months follow up