Characterizing the Use of Ofatumumab in a Real World Setting

Keywords

• ofatumumab
• NIS
• RMS

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study population

Groups and cohorts

• 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.

  Other: ofatumumab

• Part II study cohort

  Up to 100 participants responding to PROs via the MSGo Patient App

  Other: ofatumumab

Interventions

• Otherofatumumab

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

Primary outcomes

1. 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

   Time frame: Initiation

2. 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

   Time frame: First 3 months of maintenance

Secondary outcomes

1. 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

   Time frame: initiation period plus 12 months of maintenance

2. 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

   Time frame: 12 months of maintentance

3. 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

   Time frame: Up to 18 months

4. 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

   Time frame: Up to 18 months

5. 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

   Time frame: Up to 18 months

6. 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

   Time frame: 12 months

7. 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

   Time frame: during 18 months of maintenance

8. 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

   Time frame: within 18 months of the initial dose

9. 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.

   Time frame: Baseline,6 months, 12 months, 18 months

10. 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)

    Time frame: Baseline, 6 months, 12 months, 18 months

11. 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).

    Time frame: Baseline, 6 months, 12 months, 18 months

12. 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 .

    Time frame: Day 28, 6 months, 12 months, 18 months

13. 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

    Time frame: 18 months

14. 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).

    Time frame: Baseline

15. 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

    Time frame: Baseline, 6 months, 12 months

16. Part II: Annualized relapse rate

    Measured by number of relapses over a period of approximately 12 months.

    Time frame: 12 months

17. 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

    Time frame: Baseline, 6 months, 12 months

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

    Number of new or enlarging T2 lesions on MRI to be collected

    Time frame: Baseline, 6 months, 12 months

19. 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.

    Time frame: 12 months follow up

Individual participant data

Plan to share: No