A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

• 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.

• 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).

• 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.

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

Locations
Other Locations
Greece
Novartis Investigative Site
RECRUITING
Alexandroupoli
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Crete Heraklion
Novartis Investigative Site
RECRUITING
Greece
Novartis Investigative Site
RECRUITING
Ioannina
Novartis Investigative Site
RECRUITING
Larissa
Novartis Investigative Site
RECRUITING
Pátrai
Novartis Investigative Site
RECRUITING
Thessaloniki
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 160
Treatments
CHRONOS cohort
Patients prescribed with ofatumumab in a real world setting
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov