Clinical trial NCT06251986: A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice
Official title: A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice: the CRONOS-MS Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: RMS
NIS
Spain
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with relapsing forms of multiple sclerosis (RMS) with active disease

Brief summary: This is a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.

Detailed description: The present study aims to characterize the use of subcutaneous ofatumumab in a real-world setting. Specifically, the investigation will assess the effectiveness, safety, and treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing forms of multiple sclerosis (RMS) within the Spanish healthcare system.

The study will use primary and secondary data collection. Primary data collection includes information collected using PRO, clinical-reported outcomes (ClinRO), scales or tests and the interview during the study visit. Secondary data collection includes existing data from electronic medical records (EMR) or paper-based medical records, collected as part of the routine follow-up of patients with RMS in the clinical practice.

Baseline will be defined as the date of ofatumumab initiation.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years.
2. Written informed consent.
3. Diagnosis of RMS per McDonald Criteria (2017).
4. Ofatumumab treatment in line with the European Kesimpta® summary of product characteristics (SmPC; i.e. adult patients with RMS with active disease defined by clinical or imaging features) during at least 12 months and patients who discontinued ofatumumab after receiving at least one dose with a minimum monitoring of 12 months.

Exclusion Criteria:

1. Currently participating in a clinical trial.
2. Not able/unlikely to complete with all study activities according to investigator's criteria.
3. Have a contraindication for ofatumumab use, according to the SmPC.

Primary outcomes:
measure: Reductions in the Annualized relapse rate (ARR)
timeFrame: 12 months preceding the initiation of ofatumumab, Baseline
Secondary outcomes:
measure: Reductions in the ARR in naïve vs previously treated patients
timeFrame: 12 months preceding the initiation of ofatumumab, Baseline
measure: Reductions in the ARR in previously treated with high-efficacy Disease-modifying treatments (DMT) vs previously treated with moderate-efficacy DMT
timeFrame: 12 months preceding the initiation of ofatumumab, Baseline
measure: Number of days from ofatumumab treatment initiation to first relapse
timeFrame: 12 months
measure: Proportion of relapse-free patients
timeFrame: 12 months
measure: Change in EDSS score
timeFrame: Baseline, month 6, month 12
measure: Number of participants with radiological disease activity on the cranial MRI
timeFrame: Baseline, month 6, month 12
measure: Percentage of participants reporting injection site reactions (ISR)
timeFrame: Baseline, month 6, month 12
measure: Percentage of patients with AEs leading to temporal or permanent discontinuation
timeFrame: Up to 12 months
measure: Number of pregnancies and pregnancy outcome
timeFrame: Up to 12 months
measure: Proportion of participants with non-adherence
timeFrame: Up to 12 months
measure: Proportion of patients who discontinue ofatumumab during the observation period
timeFrame: Up to 12 months
measure: Scores on the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: Baseline
measure: Scores on the SDMT
timeFrame: Baseline
measure: Scores on the Modified Fatigue Impact Scale-5 (MFIS-5)
timeFrame: Baseline
measure: Scores on the EuroQol-5 dimension (EQ-5D)-5L
timeFrame: Baseline
measure: Scores on the Patients' Global Impression of Change (PGIC) scale completed by patients
timeFrame: Baseline
measure: Scores on the Clinical Global Impressions (CGI) scale completed by physicians
timeFrame: Baseline
measure: Scores on the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Baseline
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Zamora
country: Spain
facility: Novartis Investigative Site
state: Espana
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Logrono
country: Spain
facility: Novartis Investigative Site
state: La Rioja
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Caceres
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: