A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis

NCT05334472 | Completed

• 1 other identifier: COMB157GUS13
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; NIS; KESIMPTA; ofatumumab

Outcome Measures

Primary Outcomes (1)

• Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready

  Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®

  Up to 6 months, at the time of survey completion

Secondary Outcomes (18)

• Proportion of patients by US region of residence

  Up to 6 months, at the time of survey completion

• Proportion of patients by educational level

  Up to 6 months, at the time of survey completion

• Patients Determined Disease Steps (PDDS)

  Up to 6 months, at the time of survey completion

• General Health

  Up to 6 months, at the time of survey completion

• Proportion of patients by Multiple Sclerosis Phenotype

  Up to 6 months, at the time of survey completion

Study Arms (1)

Kesimpta

Patients or caregivers of patients administered Kesimpta

Other: Kesimpta

Interventions

Kesimpta OTHER

There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.

Also known as: ofatumumab

Kesimpta

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To ensure a representative sample of patients with MS, the patient study population will include patients who are new to the use of injectable treatments for MS, as well as those with use of other injectable MS treatments prior to initiation of KESIMPTA using the Sensoready® pen. Patients care partner (formal or informal) may also be eligible for study participation.

You may qualify if:

• Adult aged eighteen (18) years of age or over at the time of the survey
• Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen
• MS diagnosis based on 2017 McDonald criteria
• Adult aged eighteen (18) years of age or over
• Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months
• Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf

You may not qualify if:

• Active Hepatitis B virus (HBV)
• Cognitive impairment that would impact their ability to participate in a survey study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for COMB157GUS13 that is getting linked from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 19, 2022
• Study Start: November 24, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)