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

Novartis

Status: Completed

Conditions: Relapsing Forms of Multiple Sclerosis

Treatments: Drug: Ocrelizumab; Drug: Ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04676555

COMB157G2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2 participants in 2 patient groups

Ocrelizumab

Description:

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.

Treatment:

Drug: Ocrelizumab

Ofatumumab

Description:

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

Treatment:

Drug: Ofatumumab