Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
NCT Number: NCT06486779
Acronym: CHRONOS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Relapsing Multiple Sclerosis (RMS)
Interventions: OTHER: Ofatumumab
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2028-07-30

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)

Primary Outcome Measures: 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 Outcome Measures: Proportion of patients achieving NEDA-3 status compared to Ofatumumab 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 ofatumumab arm of Sthenos|Proportion of patients achieving each individual component of NEDA-3 compared to Ofatumumab arm of STHENOS, Achievement of NEDA-3 status and individual NEDA-3 components:

A) Proportion of patients with no confirmed multiple sclerosis clinical relapse B) Proportion of patients with no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions C) Proportion of patients with no six-month confirmed disability worsening (6m-CDW)., 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), 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)., 18 months post-enrollment|Proportion of patients achieving each individual component of NEDA-3 (no comparator), Achievement of NEDA-3 status and individual NEDA-3 components:

A) Proportion of patients with no confirmed multiple sclerosis clinical relapse B) Proportion of patients with no new or enlarging T2 lesions, no gadolinium positive (Gd+) T1 lesions C) Proportion of patients with no six-month confirmed disability worsening (6m-CDW)., 18 months post-enrollment|Proportion of patients free of 6m-RAW and 6m-PIRA - no comparator, * Proportion of patients free of 6-month confirmed relapse-associated worsening (6m-RAW)
* Proportion of patients free of 6-month confirmed progression independent of relapse activity (6m-PIRA)
* Proportion of patients free of both 6m-RAW and 6m-PIRA, 12 and 18 months post-enrollment|Change in MSIS-29 impact score from enrollment., * Change in MSIS-29 physical impact score from enrollment.
* Change in MSIS-29 psychological impact score from enrollment.

The MSIS-29 is a brief self-reported measurement of the impact of multiple sclerosis on patients' quality of life (measuring 20 items for physical \& 9 items for mental/psychological health), where high scores indicate worse health., Enrollment, 12, 18 and 24 months post-enrollment|Persistence and treatment discontinuation, Proportion of patients remaining on treatment with ofatumumab and proportion of patients permanently discontinuing ofatumumab during the study., 24 months post-enrollment|Time from the start of ofatumumab to all-cause treatment discontinuation, Time from the start of ofatumumab to all-cause treatment discontinuation, 24 months post-enrollment