Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years

NCT05776888 | Active Not Recruiting

• 1 other identifier: COMB157GAT02
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.

Conditions

Relapsing Multiple Sclerosis

Keywords

relapsing multiple sclerosis; RMS; Ofatumumab; NIS

Outcome Measures

Primary Outcomes (1)

• Proportion of patients demonstrating NEDA-3

  Proportion and comparison of patients in both cohorts achieving NEDA-3 in the second year after treatment initiation, which refers to a comparison between month 12 and 24 after Ofatumumab treatment was initiated. NEDA-3 is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no new Gadolinium-positive T1 lesions (in case Gadolinium was utilized), and no six-month confirmed disability worsening.

  from month 12 up to month 24

Secondary Outcomes (2)

• Proportion of patients displaying NEDA-3, as well as individual NEDA components

  Baseline, month 12, month 24

• Proportion of patients permanently discontinuing Ofatumumab during the study

  Up to 24 months

Study Arms (2)

Early Treatment Cohort (Cohort 1)

Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation.

Other: Ofatumumab

Later Treatment Cohort (Cohort 2)

Patients that have been on BRACE and/or Teriflunomide and/or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated.

Other: Ofatumumab

Interventions

Ofatumumab OTHER

There is no treatment allocation. For both cohorts, only patients that have received Ofatumumab treatment for at least 3 months prior to inclusion in the study will be enrolled.

Early Treatment Cohort (Cohort 1); Later Treatment Cohort (Cohort 2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab

You may qualify if:

• Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.
• Written informed consent must be obtained before participating in the study.
• Patient is willing and able to complete the assessments, as outlined in this study.
• Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
• Cohort 1: Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation.
• Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.

You may not qualify if:

• Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod, Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron or Cladribine) in either cohort prior to the initiation of Ofatumumab.
• Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the initiation of Ofatumumab.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 20, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share