A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice

Relapsing Forms of Multiple Sclerosis Clinical Trial

— CRONOS-MS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251986
• Other study ID #: COMB157GES01
• Status: Recruiting
• Start date: February 26, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Other:
• ofatumumab
This is an observational study, there is no treatment allocation.

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Albacete	Castilla La Mancha
Spain	Novartis Investigative Site	Caceres
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Granada
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Leon
Spain	Novartis Investigative Site	Logrono	La Rioja
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Palma De Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Santiago De Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Vigo	Pontevedra
Spain	Novartis Investigative Site	Zamora	Espana
Spain	Novartis Investigative Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in the Annualized relapse rate (ARR)	ARR is defined as the total number of confirmed relapses that occurred during the observation period divided by the total number of patient-years, with the result standardized to a 1-year period.; A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for = 30 days	12 months preceding the initiation of ofatumumab, Baseline
Secondary	Reductions in the ARR in naïve vs previously treated patients	ARR is defined as the total number of confirmed relapses that occurred during the observation period divided by the total number of patient-years, with the result standardized to a 1-year period.; A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for = 30 days	12 months preceding the initiation of ofatumumab, Baseline
Secondary	Reductions in the ARR in previously treated with high-efficacy Disease-modifying treatments (DMT) vs previously treated with moderate-efficacy DMT	ARR is defined as the total number of confirmed relapses that occurred during the observation period divided by the total number of patient-years, with the result standardized to a 1-year period.; A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for = 30 days	12 months preceding the initiation of ofatumumab, Baseline
Secondary	Number of days from ofatumumab treatment initiation to first relapse	A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for = 30 days	12 months
Secondary	Proportion of relapse-free patients	A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for = 30 days	12 months
Secondary	Change in EDSS score	The Expanded Disability Status Scale (EDSS) is the most widely disability scale used in MS. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.	Baseline, month 6, month 12
Secondary	Number of participants with radiological disease activity on the cranial MRI	Number of participants with presence of radiological disease activity on the cranial MRI	Baseline, month 6, month 12
Secondary	Percentage of participants reporting injection site reactions (ISR)	Percentage of participants reporting injection site reactions (ISR) will be collected	Baseline, month 6, month 12
Secondary	Percentage of patients with AEs leading to temporal or permanent discontinuation	Percentage of patients with AEs leading to temporal or permanent discontinuation will be collected	Up to 12 months
Secondary	Number of pregnancies and pregnancy outcome	Number of pregnancies and pregnancy outcome will be collected	Up to 12 months
Secondary	Proportion of participants with non-adherence	Non-adherence, defined as skipping at least one dose during initial dosing (i.e. missing one weekly injections, defined as not receiving the dose within the established 7 and 14 days after the prior dose) or during maintenance dosing (missing one monthly injection, defined as not receiving the dose within the established month after the prior dose) as per SmPC.	Up to 12 months
Secondary	Proportion of patients who discontinue ofatumumab during the observation period	Proportion of patients who discontinue ofatumumab during the observation period will be collected	Up to 12 months
Secondary	Scores on the Work Productivity and Activity Impairment (WPAI) questionnaire	The WPAI is an instrument to assess impairments in both paid work and unpaid work. Using six questions, it measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days.; The first question is neutral. In the 2nd 3rd 5th and 6th questions a higher score means worse outcome. In the 4th question a higher score means better outcome.	Baseline
Secondary	Scores on the SDMT	Symbol Digit Modalities Test (SDMT) is a measure of sustained attention, processing speed, visual scanning, and motor speed. This test involves a coding schema consisting of nine abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The score is the number of correctly coded items from 0-110 where higher scores indicate better result.	Baseline
Secondary	Scores on the Modified Fatigue Impact Scale-5 (MFIS-5)	The MFIS-5 measures the impact of fatigue on cognitive, physical, and psychosocial function. The MFIS-5 is a self-administered questionnaire with a 5-point Likert scoring system that best indicates how often fatigue has affected patients during the past 4 weeks: 'never', 'rarely', 'sometimes', 'often' and 'almost always', each scored 0-4, respectively. It consists of 5 of the 21 items of MFIS that most strongly correlate with the total MFIS score. The sum provides a total score from 0 to 20. Higher scores indicate a higher perception of fatigue.	Baseline
Secondary	Scores on the EuroQol-5 dimension (EQ-5D)-5L	The EQ-5D-5L is a generic measure for Health-related quality of life. It consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels( 1=no problems to 5= extreme problems). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. In the VAS, 100 indicates the best health status.	Baseline
Secondary	Scores on the Patients' Global Impression of Change (PGIC) scale completed by patients	The PGIC is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. The PGIC will ask: "Since beginning treatment, how would you describe the change (if any) in activity limitations, symptoms, emotions and overall quality of life, related to your MS? Responses will range from 1= very much improved to 7= very much worse.	Baseline
Secondary	Scores on the Clinical Global Impressions (CGI) scale completed by physicians	The CGI provides an overall clinician-determined summary measure that considers all available information, including the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.; The CGI-Improvement will be used in this study. The clinician compares the patient's overall clinical condition to the one week period just prior to the initiation of medication use. The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.	Baseline
Secondary	Scores on the Treatment Satisfaction Questionnaire for Medication (TSQM-9)	The TSQM-9 is a widely used generic measure to assess treatment satisfaction with their medication.; The TSQM-9 uses nine of the 14 TSQM Version 1.4 items not including five TSQM questions related to side effects. The TSQM-9 encompasses three subscales that assess the patient's perception of medication effectiveness, convenience, and global satisfaction. Each TSQM-9 subscale consists of three items, with responses measured on a Likert scale ranging from 1 (low) to 7 (high). Subscale scores are usually transformed to a range from 0 to 100, with higher scores indicating greater satisfaction.	Baseline