Multiple SclerosisNCT05334472
A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Kesimpta
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2021to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Patients with MS Inclusion Criteria:
- 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
Care Partner Inclusion 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
Patients with MS Exclusion Criteria:
- Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial
- Active Hepatitis B virus (HBV)
- Cognitive impairment that would impact their ability to participate in a survey study
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: Real World Study to Evaluate Patient and Care Partner Ratings on Early Experience of Injection and Device for KESIMPTA® (Ofatumumab) Indicated for Multiple Sclerosis
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.
Read the detailed description
The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.
Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.
- Conditions
- Multiple Sclerosis
- Being tested
- Kesimpta
- Keywords
- Multiple Sclerosis, MS, NIS, KESIMPTA, ofatumumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KesimptaOther
Also called ofatumumab
There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Kesimpta | Patients or caregivers of patients administered Kesimpta Receives: Other: Kesimpta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®
Measured: Up to 6 months, at the time of survey completion
Secondary outcomes (18)
Proportion of patients by US region of residence
Census US geographic region of residence (Northeast, Midwest, South, or West)
Measured: Up to 6 months, at the time of survey completion
Proportion of patients by educational level
Proportion of patients by educational level was collected
Measured: Up to 6 months, at the time of survey completion
Patients Determined Disease Steps (PDDS)
PDDS was used as a proxy to Expanded Disability Status Scale (EDSS). People were asked to choose one out of nine options that best describes how well they walk. 0 is "normal" and 8 is "bedridden."
Measured: Up to 6 months, at the time of survey completion
General Health
Participants were asked "How is your general health today?" and they had to choose one out of five options that best describes how well they feel from "Poor", "Fair" ,"Good", "Very Good" to "Excellent".
Measured: Up to 6 months, at the time of survey completion
Proportion of patients by Multiple Sclerosis Phenotype
Proportion of patients by Multiple Sclerosis Phenotype was collected:
- RRMS: Relapsing-Remitting Multiple Sclerosis
- SPMS: Secondary Progressive Multiple Sclerosis
Measured: Up to 6 months, at the time of survey completion
Proportion of patients with co-morbidities
Proportion of patients with co-morbidities was collected
Measured: Up to 6 months, at the time of survey completion
Importance of healthcare provider (HCP) instructions for first injection
Participants were asked to rate their level of agreement with each statement related to their first Kesimpta injection. 1) I felt it was essential to have a healthcare provider instruct me on how to perform my first KESIMPTA injection using the Sensoready® pen, 2) I felt I needed to have a healthcare provider watch me administer my first KESIMPTA injection using the Sensoready® pen, and 3) I felt comfortable receiving instructions from my healthcare provider in the clinic on how to administer my first KESIMPTA injection using the Sensoready® pen and did not need my healthcare provider to be present to administer it at home.
Participants were asked to choose five options toward each statement from "Strongly Disagree" to "Strongly Agree".
Measured: Up to 6 months, at the time of survey completion
Level of anxiety with injections, in general
Participants were asked "Using a scale of 0 to 10, 0 being Not at All Confident and 10 being Extremely Confident, how confident do you feel about your ability to administer KESIMPTA using the Sensoready® pen on your own?"
Measured: Up to 6 months, at the time of survey completion
Proportion of patients performing preparation activities for injection
Proportion of patients performing preparation activities for injection:
- Time to take KESIMPTA Sensoready® pen out of the refrigerator and allow it to reach room temperature prior to injection (minutes) (step A)
- Time to perform the injection including picking up the Sensoready® pen, injecting and disposing in the sharps container (minutes) (step B)
Measured: Up to 6 months, at the time of survey completion
Proportion of participants by site of administration
Proportion of participants by site of administration was collected:
- thigh
- abdomen
- upper outer arm
Measured: Up to 6 months, at the time of survey completion
Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)
Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) was collected among DMT experienced patients
Measured: Up to 6 months, at the time of survey completion
Proportion of patients who are DMT naïve or experienced
Proportion pf patients who are DMT naïve or experienced was collected.
Measured: Up to 6 months, at the time of survey completion
Proportion of participants by reasons for starting KESIMPTA
Proportion of participants by reasons for starting KESIMPTA was collected:
- ease of dosing schedule
- avoidance of infusion clinics
- at home convenience
- enhanced efficacy and safety profile
- HCP recommendation
- lack of insurance coverage for other DMTs
- Other
Measured: Up to 6 months, at the time of survey completion
Proportion of participants by reasons to switch from most recent therapy
Proportion of participants by reasons to switch from most recent therapy (insurance, lack of efficacy/wear off effect, side-effects and tolerability, adherence concerns etc.) was collected among DMT experienced patients.
Measured: Up to 6 months, at the time of survey completion
Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration
Percentage of patients who agree with each attribute of the device Usability Characteristics during self-administration, based on patient self-report was collected:
- Overall ease of use
- Device ergonomics ("feeling" in the hand )
- Steps for preparing and using device
- Time required for preparation and use of device
- Convenience/Flexibility for travel with device
Measured: Up to 6 months, at the time of survey completion
Patient Confidence
Percentage o patients who agree with each attribute regarding confidence, based on patient self-report, was collected:
- Confidence to self-administer KESIMPTA using the device
- Intention to continue use of device
- Recommendation of KESIMPTA device use to others
- Ease of KESIMPTA's monthly dosing schedule
Measured: Up to 6 months, at the time of survey completion
Overall device satisfaction by treatment duration
Overall device satisfaction. Participants choose between five options from 1: Extremely Dissatisfied, 2 Dissatisfied, 3: Neither Satisfied nor Dissatisfied, 4: Satisfied, 5: Extremely Satisfied. The higher score means a better overall devise satisfaction.
Measured: Up to 6 months, at the time of survey completion
Overall device satisfaction score of the study participants by DMT experience
Percentage of patients by overall satisfaction score (extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, extremely satisfied) by DMT experience
Measured: Up to 6 months, at the time of survey completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start24 Nov 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334472
- Sponsor's protocol ID
- COMB157GUS13
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study to Evaluate Patient and Care Partner Ratings on Early Experience of Injection and Device for KESIMPTA® (Ofatumumab) Indicated for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05334472
- Acronym / sponsor ID
- COMB157GUS13
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, NIS, KESIMPTA, ofatumumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.
Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kesimpta | – | Other: KesimptaPatients or caregivers of patients administered Kesimpta |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KesimptaAlso: ofatumumabThere was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled. | Other | Kesimpta |
Primary outcome
Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready
Time frame: Up to 6 months, at the time of survey completion
Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®
18 secondary outcomes
Proportion of patients by US region of residence
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients by educational level
Time frame: Up to 6 months, at the time of survey completion
Patients Determined Disease Steps (PDDS)
Time frame: Up to 6 months, at the time of survey completion
General Health
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients by Multiple Sclerosis Phenotype
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients with co-morbidities
Time frame: Up to 6 months, at the time of survey completion
Importance of healthcare provider (HCP) instructions for first injection
Time frame: Up to 6 months, at the time of survey completion
Level of anxiety with injections, in general
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients performing preparation activities for injection
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by site of administration
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients who are DMT naïve or experienced
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by reasons for starting KESIMPTA
Time frame: Up to 6 months, at the time of survey completion
Proportion of participants by reasons to switch from most recent therapy
Time frame: Up to 6 months, at the time of survey completion
Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration
Time frame: Up to 6 months, at the time of survey completion
Patient Confidence
Time frame: Up to 6 months, at the time of survey completion
Overall device satisfaction by treatment duration
Time frame: Up to 6 months, at the time of survey completion
Overall device satisfaction score of the study participants by DMT experience
Time frame: Up to 6 months, at the time of survey completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Results for COMB157GUS13 that is getting linked from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready (time frame: Up to 6 months, at the time of survey completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.