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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05090033
Registration number
NCT05090033
Ethics application status
Date submitted
22/09/2021
Date registered
22/10/2021
Titles & IDs
Public title
Characterizing the Use of Ofatumumab in a Real World Setting
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Scientific 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)
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Secondary ID [1]
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COMB157GAU01
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Universal Trial Number (UTN)
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Trial acronym
EAFToS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - ofatumumab
Part I study cohort - Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App.
Part II study cohort - Up to 100 participants responding to PROs via the MSGo Patient App
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part I and II: Proportion of doses not completed within three days of the expected date
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Assessment method [1]
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Proportion of doses not completed within three days of the expected date during initiation to be collected
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Timepoint [1]
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Initiation
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Primary outcome [2]
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Part I and II: Proportion of doses not completed within 3 days of the expected date
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Assessment method [2]
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Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected
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Timepoint [2]
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First 3 months of maintenance
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Secondary outcome [1]
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Part I: Proportion of doses not completed within three days of the expected date
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Assessment method [1]
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Proportion of doses not completed within three days of the expected date to be collected
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Timepoint [1]
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initiation period plus 12 months of maintenance
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Secondary outcome [2]
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Part I: Proportion of doses not completed within 14 days of the expected date
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Assessment method [2]
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Proportion of doses not completed within 14 days of the expected date to be collected
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Timepoint [2]
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12 months of maintentance
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Secondary outcome [3]
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Part I: Proportion of participants with a treatment interruption of more than six months during maintenance
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Assessment method [3]
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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
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Timepoint [3]
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Up to 18 months
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Secondary outcome [4]
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Part I: Proportion of participants discontinued within three months of the intial dose
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Assessment method [4]
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Proportion of participants discontinued within three months of the intial dose to be collected
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Timepoint [4]
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Up to 18 months
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Secondary outcome [5]
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Part I: Proportion of participants discontinued within 12 months of the intial dose.
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Assessment method [5]
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Proportion of participants discontinued within 12 months of the initial dose to be collected
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Timepoint [5]
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Up to 18 months
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Secondary outcome [6]
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Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups
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Assessment method [6]
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Patient sub-groups will be compared to either other complementary sub-groups or the "all patients" cohort
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Part II: Proportion of doses not completed within 14 days of the expected date
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Assessment method [7]
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This outcome measure will be measured for those patients who have MRI completed at approximately 18 months
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Timepoint [7]
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during 18 months of maintenance
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Secondary outcome [8]
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Part II: proportion of participants discontinued within 18 months of the intial dose
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Assessment method [8]
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This outcome measure will be measured for those patients who have MRI completed at approximately 18 months
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Timepoint [8]
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within 18 months of the initial dose
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Secondary outcome [9]
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Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline,6 months, 12 months, 18 months
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Secondary outcome [10]
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Part II: Change in generic health status as measured by the EQ5D
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Assessment method [10]
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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)
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Timepoint [10]
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Baseline, 6 months, 12 months, 18 months
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Secondary outcome [11]
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Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).
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Assessment method [11]
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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).
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Timepoint [11]
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Baseline, 6 months, 12 months, 18 months
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Secondary outcome [12]
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Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)
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Assessment method [12]
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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 .
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Timepoint [12]
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Day 28, 6 months, 12 months, 18 months
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Secondary outcome [13]
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Part II: Proportion of self administration
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Assessment method [13]
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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
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Timepoint [13]
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18 months
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Secondary outcome [14]
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Part II: Proportion of patients initiating ofatumumab who are treatment naïve
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Assessment method [14]
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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).
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Timepoint [14]
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Baseline
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Secondary outcome [15]
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Part II: Change in Expanded Disability Status Scale (EDSS)
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Assessment method [15]
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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
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Timepoint [15]
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Baseline, 6 months, 12 months
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Secondary outcome [16]
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Part II: Annualized relapse rate
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Assessment method [16]
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Measured by number of relapses over a period of approximately 12 months.
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Part II: Number of T1 Gd-enhancing lesions per MRI scan
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Assessment method [17]
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This will only be assessed where gadolinium is used as per Institution's usual practice. Otherwise, this will not be reported
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Timepoint [17]
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Baseline, 6 months, 12 months
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Secondary outcome [18]
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Part II: Number of new or enlarging T2 lesions on MRI
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Assessment method [18]
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Number of new or enlarging T2 lesions on MRI to be collected
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Timepoint [18]
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Baseline, 6 months, 12 months
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Secondary outcome [19]
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Percentage brain volume change
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Assessment method [19]
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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.
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Timepoint [19]
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12 months follow up
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Concord
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Recruitment hospital [2]
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Novartis Investigative Site - St Leonards
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Recruitment hospital [3]
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Novartis Investigative Site - Southport
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Recruitment hospital [4]
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Novartis Investigative Site - Box Hill
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Recruitment hospital [5]
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Novartis Investigative Site - Clayton
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Recruitment hospital [6]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [7]
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Novartis Investigative Site - Nedlands
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Recruitment hospital [8]
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Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4222 - Southport
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment postcode(s) [8]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05090033
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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+41613241111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05090033