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

NCT04676555 | Completed

• 1 other identifier: COMB157G2004
• Study Type: observational
• Target: 2
• Locations: 2 countries
• Sites: 2

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Keywords

Relapsing forms of Multiple Sclerosis; RMS; Ocrelizumab; Ofatumumab; TIMIOS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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

Ofatumumab

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

Drug: Ofatumumab

Interventions

Ocrelizumab DRUG

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

Ocrelizumab

Ofatumumab DRUG

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

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed of RMS will be recruited if they have been prescribed either Ocrelizumab of Ofatumumab. The person accompanying the patient will be invited to participate as a caregiver.

You may qualify if:

• 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.

You may not qualify if:

• Patients currently participating in any other RMS clinical trial.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Lutherville, Maryland, 21093, United States

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Interventions

ocrelizumab; ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: May 11, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (1)