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

NCT ID: NCT05776888

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2026-08-31

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.

Detailed Description

This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.

Conditions

Relapsing Multiple Sclerosis

Keywords

relapsing multiple sclerosis; RMS; Ofatumumab; NIS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ofatumumab

Intervention Type: 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.

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.

Ofatumumab

Intervention Type: 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.

Interventions

Ofatumumab

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.

2. Written informed consent must be obtained before participating in the study.

3. Patient is willing and able to complete the assessments, as outlined in this study.

4. Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.

5. Patients in both cohorts must have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.

6. 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.

7. 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.

Exclusion Criteria

1. Patients who have been on Ofatumumab less than 3 months or more than 12 months before inclusion.

2. Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.

3. 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.

4. Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the initiation of Ofatumumab.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Countries

Austria

Other Identifiers

COMB157GAT02

Identifier Type: -

Identifier Source: org_study_id