Characterizing the Use of Ofatumumab in a Real World Setting

• Register: ClinicalTrials.gov
• Last refreshed on: 27 January 2025
• Main ID: NCT05090033
• Date of registration: 22/09/2021
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Characterizing the Use of Ofatumumab in a Real World Setting EAFToS
• 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)
• Date of first enrolment: December 8, 2022
• Target sample size: 103
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05090033
• Study type: Observational

Countries of recruitment

Australia

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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].


Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Other: ofatumumab

Primary Outcome(s)

Part I and II: Proportion of doses not completed within 3 days of the expected date [Time Frame: First 3 months of maintenance]

Part I and II: Proportion of doses not completed within three days of the expected date [Time Frame: Initiation]

Secondary Outcome(s)

Part I: Proportion of doses not completed within three days of the expected date [Time Frame: initiation period plus 12 months of maintenance]

Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups [Time Frame: 12 months]

Part I: Proportion of participants with a treatment interruption of more than six months during maintenance [Time Frame: Up to 18 months]

Part II: Annualized relapse rate [Time Frame: 12 months]

Part II: Change in Expanded Disability Status Scale (EDSS) [Time Frame: Baseline, 6 months, 12 months]

Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire [Time Frame: Baseline,6 months, 12 months, 18 months]

Part II: Number of new or enlarging T2 lesions on MRI [Time Frame: Baseline, 6 months, 12 months]

Part II: Proportion of patients initiating ofatumumab who are treatment naïve [Time Frame: Baseline]

Part I: Proportion of participants discontinued within 12 months of the intial dose. [Time Frame: Up to 18 months]

Part II: proportion of participants discontinued within 18 months of the intial dose [Time Frame: within 18 months of the initial dose]

Percentage brain volume change [Time Frame: 12 months follow up]

Part I: Proportion of participants discontinued within three months of the intial dose [Time Frame: Up to 18 months]

Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4) [Time Frame: Day 28, 6 months, 12 months, 18 months]

Part II: Proportion of self administration [Time Frame: 18 months]

Part I: Proportion of doses not completed within 14 days of the expected date [Time Frame: 12 months of maintentance]

Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC). [Time Frame: Baseline, 6 months, 12 months, 18 months]

Part II: Number of T1 Gd-enhancing lesions per MRI scan [Time Frame: Baseline, 6 months, 12 months]

Part II: Proportion of doses not completed within 14 days of the expected date [Time Frame: during 18 months of maintenance]

Part II: Change in generic health status as measured by the EQ5D [Time Frame: Baseline, 6 months, 12 months, 18 months]

Secondary ID(s)

COMB157GAU01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors