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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT04676555
Collaborator
(none)
2
2
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
2 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis
Actual Study Start Date :
May 11, 2021
Actual Primary Completion Date :
Oct 21, 2021
Actual Study Completion Date :
Oct 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Ocrelizumab

Ocrelizumab is administered intravenously (IV) under the guidance of a specialized physician and followed by one-hour observation after the infusion. It requires a corticosteroid pre-medication and some antipyretics may also be administered.

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

Ofatumumab is administered through a subcutaneous injection and allows self-administration after training.

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab [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)]

    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).

Secondary Outcome Measures

  1. Healthcare resources used, in terms of consumables in the treatment preparation and administration of Ocrelizumab and Ofatumumab [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)]

    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.

  2. Cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab [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)]

    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.

  3. 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 [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)]

    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.

  4. Healthcare resources used, in terms of consumables in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab [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)]

    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.

  5. Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS [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)]

    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

  6. Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG) [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)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Lutherville Maryland United States 21093
2 Novartis Investigative Site Parkville Victoria Australia 3050

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04676555
Other Study ID Numbers:
  • COMB157G2004
First Posted:
Dec 21, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022