Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study

NCT06486779 | Recruiting

• 1 other identifier: COMB157GGR01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 14

Brief Summary

This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)

Conditions

Relapsing Multiple Sclerosis (RMS)

Keywords

Relapsing Multiple Sclerosis (RMS); RMS; NIS; Greece; Ofatumumab; Kesimpta

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with no evidence of disease activity (NEDA-3) compared to SoC arm of STHENOS

  Achievement of NEDA-3 status (no evidence of disease activity based on three components): A) No confirmed multiple sclerosis clinical relapse B) No new MRI brain activity (no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions) C) No six-month confirmed disability worsening (6m-CDW).

  12 months post-enrollment for Chronos cohort and 15 months post-baseline for SoC arm of Sthenos

Secondary Outcomes (8)

• Proportion of patients achieving NEDA-3 status compared to Ofatumumab arm of STHENOS

  12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos

• Proportion of patients achieving each individual component of NEDA-3 compared to Ofatumumab arm of STHENOS

  12 months post-enrollment for Chronos cohort and 15 months post-baseline for ofatumumab arm of Sthenos

• Proportion of patients achieving NEDA-3 status (no comparator)

  18 months post-enrollment

• Proportion of patients achieving each individual component of NEDA-3 (no comparator)

  18 months post-enrollment

• Proportion of patients free of 6m-RAW and 6m-PIRA - no comparator

  12 and 18 months post-enrollment

Study Arms (1)

CHRONOS cohort

Patients prescribed with ofatumumab in a real world setting

Other: Ofatumumab

Interventions

Ofatumumab OTHER

This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.

CHRONOS cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with RMS who have initiated treatment with ofatumumab early in their disease course. Patients will have been administered ofatumumab (Kesimpta®) three to six months prior to informed consent (IC) and will continue to be treated according to the local product's prescribing information and routine medical practice in terms of visit frequency and type of assessments performed, after enrolment.

You may qualify if:

• Written IC must be obtained before participating in the study.
• Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab.
• Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).
• Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.
• Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.

You may not qualify if:

• Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigative Site

Alexandroupoli, 681 00, Greece

RECRUITING

Novartis Investigative Site

Athens, 115 21, Greece

RECRUITING

Novartis Investigative Site

Athens, 115 25, Greece

RECRUITING

Novartis Investigative Site

Athens, 115 27, Greece

RECRUITING

Novartis Investigative Site

Athens, 115 28, Greece

RECRUITING

Novartis Investigative Site

Athens, 145 61, Greece

ACTIVE NOT RECRUITING

Novartis Investigative Site

Athens, 185 47, Greece

RECRUITING

Novartis Investigative Site

Chaïdári, 124 62, Greece

RECRUITING

Novartis Investigative Site

Crete Heraklion, 714 09, Greece

RECRUITING

Novartis Investigative Site

Ioannina, 455 00, Greece

RECRUITING

Novartis Investigative Site

Larissa, 411 10, Greece

RECRUITING

Novartis Investigative Site

Pátrai, 265 04, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, 53246, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, GR 54636, Greece

RECRUITING

MeSH Terms

Interventions

ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (14)