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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
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)
Secondary ID [1] 0 0
COMB157GAU01
Universal Trial Number (UTN)
Trial acronym
EAFToS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part I and II: Proportion of doses not completed within three days of the expected date
Timepoint [1] 0 0
Initiation
Primary outcome [2] 0 0
Part I and II: Proportion of doses not completed within 3 days of the expected date
Timepoint [2] 0 0
First 3 months of maintenance
Secondary outcome [1] 0 0
Part I: Proportion of doses not completed within three days of the expected date
Timepoint [1] 0 0
initiation period plus 12 months of maintenance
Secondary outcome [2] 0 0
Part I: Proportion of doses not completed within 14 days of the expected date
Timepoint [2] 0 0
12 months of maintentance
Secondary outcome [3] 0 0
Part I: Proportion of participants with a treatment interruption of more than six months during maintenance
Timepoint [3] 0 0
Up to 18 months
Secondary outcome [4] 0 0
Part I: Proportion of participants discontinued within three months of the intial dose
Timepoint [4] 0 0
Up to 18 months
Secondary outcome [5] 0 0
Part I: Proportion of participants discontinued within 12 months of the intial dose.
Timepoint [5] 0 0
Up to 18 months
Secondary outcome [6] 0 0
Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Part II: Proportion of doses not completed within 14 days of the expected date
Timepoint [7] 0 0
during 18 months of maintenance
Secondary outcome [8] 0 0
Part II: proportion of participants discontinued within 18 months of the intial dose
Timepoint [8] 0 0
within 18 months of the initial dose
Secondary outcome [9] 0 0
Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
Timepoint [9] 0 0
Baseline,6 months, 12 months, 18 months
Secondary outcome [10] 0 0
Part II: Change in generic health status as measured by the EQ5D
Timepoint [10] 0 0
Baseline, 6 months, 12 months, 18 months
Secondary outcome [11] 0 0
Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).
Timepoint [11] 0 0
Baseline, 6 months, 12 months, 18 months
Secondary outcome [12] 0 0
Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)
Timepoint [12] 0 0
Day 28, 6 months, 12 months, 18 months
Secondary outcome [13] 0 0
Part II: Proportion of self administration
Timepoint [13] 0 0
18 months
Secondary outcome [14] 0 0
Part II: Proportion of patients initiating ofatumumab who are treatment naïve
Timepoint [14] 0 0
Baseline
Secondary outcome [15] 0 0
Part II: Change in Expanded Disability Status Scale (EDSS)
Timepoint [15] 0 0
Baseline, 6 months, 12 months
Secondary outcome [16] 0 0
Part II: Annualized relapse rate
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Part II: Number of T1 Gd-enhancing lesions per MRI scan
Timepoint [17] 0 0
Baseline, 6 months, 12 months
Secondary outcome [18] 0 0
Part II: Number of new or enlarging T2 lesions on MRI
Timepoint [18] 0 0
Baseline, 6 months, 12 months
Secondary outcome [19] 0 0
Percentage brain volume change
Timepoint [19] 0 0
12 months follow up

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.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [2] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [3] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [4] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [5] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [6] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [7] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
+41613241111
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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