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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05090033

Registration number

NCT05090033

Ethics application status

Date submitted

22/09/2021

Date registered

22/10/2021

Date last updated

6/12/2023

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]

COMB157GAU01

Universal Trial Number (UTN)

Trial acronym

EAFToS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Relapsing Multiple Sclerosis

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part I and II: Proportion of doses not completed within three days of the expected date

Timepoint [1]

Initiation

Primary outcome [2]

Part I and II: Proportion of doses not completed within 3 days of the expected date

Timepoint [2]

First 3 months of maintenance

Secondary outcome [1]

Part I: Proportion of doses not completed within three days of the expected date

Timepoint [1]

initiation period plus 12 months of maintenance

Secondary outcome [2]

Part I: Proportion of doses not completed within 14 days of the expected date

Timepoint [2]

12 months of maintentance

Secondary outcome [3]

Part I: Proportion of participants with a treatment interruption of more than six months during maintenance

Timepoint [3]

Up to 18 months

Secondary outcome [4]

Part I: Proportion of participants discontinued within three months of the intial dose

Timepoint [4]

Up to 18 months

Secondary outcome [5]

Part I: Proportion of participants discontinued within 12 months of the intial dose.

Timepoint [5]

Up to 18 months

Secondary outcome [6]

Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups

Timepoint [6]

12 months

Secondary outcome [7]

Part II: Proportion of doses not completed within 14 days of the expected date

Timepoint [7]

during 18 months of maintenance

Secondary outcome [8]

Part II: proportion of participants discontinued within 18 months of the intial dose

Timepoint [8]

within 18 months of the initial dose

Secondary outcome [9]

Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire

Timepoint [9]

Baseline,6 months, 12 months, 18 months

Secondary outcome [10]

Part II: Change in generic health status as measured by the EQ5D

Timepoint [10]

Baseline, 6 months, 12 months, 18 months

Secondary outcome [11]

Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).

Timepoint [11]

Baseline, 6 months, 12 months, 18 months

Secondary outcome [12]

Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)

Timepoint [12]

Day 28, 6 months, 12 months, 18 months

Secondary outcome [13]

Part II: Proportion of self administration

Timepoint [13]

18 months

Secondary outcome [14]

Part II: Proportion of patients initiating ofatumumab who are treatment naïve

Timepoint [14]

Baseline

Secondary outcome [15]

Part II: Change in Expanded Disability Status Scale (EDSS)

Timepoint [15]

Baseline, 6 months, 12 months

Secondary outcome [16]

Part II: Annualized relapse rate

Timepoint [16]

12 months

Secondary outcome [17]

Part II: Number of T1 Gd-enhancing lesions per MRI scan

Timepoint [17]

Baseline, 6 months, 12 months

Secondary outcome [18]

Part II: Number of new or enlarging T2 lesions on MRI

Timepoint [18]

Baseline, 6 months, 12 months

Secondary outcome [19]

Percentage brain volume change

Timepoint [19]

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

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

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

30/06/2025

Actual

Sample size

Target

1500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC,WA

Recruitment hospital [1]

Novartis Investigative Site - Concord

Recruitment hospital [2]

Novartis Investigative Site - St Leonards

Recruitment hospital [3]

Novartis Investigative Site - Southport

Recruitment hospital [4]

Novartis Investigative Site - Box Hill

Recruitment hospital [5]

Novartis Investigative Site - Clayton

Recruitment hospital [6]

Novartis Investigative Site - Melbourne

Recruitment hospital [7]

Novartis Investigative Site - Nedlands

Recruitment hospital [8]

Novartis Investigative Site - Heidelberg

Recruitment postcode(s) [1]

2139 - Concord

Recruitment postcode(s) [2]

2065 - St Leonards

Recruitment postcode(s) [3]

4222 - Southport

Recruitment postcode(s) [4]

3128 - Box Hill

Recruitment postcode(s) [5]

3168 - Clayton

Recruitment postcode(s) [6]

3004 - Melbourne

Recruitment postcode(s) [7]

6009 - Nedlands

Recruitment postcode(s) [8]

3084 - Heidelberg

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Novartis Pharmaceuticals

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/ct2/show/NCT05090033

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Novartis Pharmaceuticals

Address

Novartis Pharmaceuticals

Country

Phone

Fax

Contact person for public queries

Name

Novartis Pharmaceuticals

Address

Country

Phone

+41613241111

Fax

novartis.email@novartis.com

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05090033

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05090033