Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis Clinical Trial

— TIMIOS  

Official title:

Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676555
• Other study ID #: COMB157G2004
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: October 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.

Description:

Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients of 18 or more years of age.
• Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria.
• Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study.
• Patients literate in English.
• Patients must provide informed consent to participate in the study.

Exclusion Criteria:

• Patients currently participating in any other RMS clinical trial.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Parkville	Victoria
United States	Novartis Investigative Site	Lutherville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab	Describe and compare the time spent by Healthcare Providers (in minutes) in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab in patients with Relapsing forms of Multiple Sclerosis at each event (initial, loading and subsequent doses).	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Healthcare resources used, in terms of consumables in the treatment preparation and administration of Ocrelizumab and Ofatumumab	Describe and compare the healthcare resources used, in terms of number of consumables used, in the treatment preparation and administration of Ocrelizumab and Ofatumumab for RMS patients at each event.	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab	Describe and compare the cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab for RMS patients at each event.	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab	Describe and compare the healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event.	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Healthcare resources used, in terms of consumables in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab	Describe and compare the healthcare resources used, in terms of number of consumables used in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event.	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS	Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS) at each event.; The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary	Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG)	Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG), at each event.; The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity	Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)