MedDataX Logo

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

NCT ID: NCT06486779

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2028-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years, and will be compared to the ofatumumab and Standard of Care (SoC) arms of the STHENOS trial, a closely monitored phase-IIIb trial. Eligible patients are those with Relapsing Multiple Sclerosis (RMS) diagnosis, with 1st MS symptom within 5 years prior to ofatumumab's initiation and on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study. The overall study duration is expected to be 48 months, including a recruitment period and a per-patient observation period of 24 months each. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 6-, 12-, 18-, and 24-month data collection timepoints post with an allowable time window of ±1 month for all data collection timepoints. NEDA-3 status, MS Relapse, EDSS, MRI, PROs questionnaires, MSIS-29, SDMT, Adherence and persistence, AEs will be assessed during the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsing Multiple Sclerosis (RMS)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Greece Ofatumumab Kesimpta Relapsing Multiple Sclerosis (RMS) RMS NIS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHRONOS cohort

Patients prescribed with ofatumumab in a real world setting

Ofatumumab

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ofatumumab

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written IC must be obtained before participating in the study.
2. Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab.
3. Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.
4. 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).
5. Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.

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.
6. Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.

Exclusion Criteria

1. Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Alexandroupoli, , Greece

Site Status RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Athens, , Greece

Site Status RECRUITING

Novartis Investigative Site

Chaïdári, , Greece

Site Status RECRUITING

Novartis Investigative Site

Crete Heraklion, , Greece

Site Status RECRUITING

Novartis Investigative Site

Ioannina, , Greece

Site Status RECRUITING

Novartis Investigative Site

Larissa, , Greece

Site Status RECRUITING

Novartis Investigative Site

Pátrai, , Greece

Site Status RECRUITING

Novartis Investigative Site

Thessaloniki, , Greece

Site Status RECRUITING

Novartis Investigative Site

Thessaloniki, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COMB157GGR01

Identifier Type: -

Identifier Source: org_study_id