Clinical trial NCT05627271: The 'Wearing Off' Effect of DMT
Official title: Understanding the 'Wearing Off' Effect From Disease-modifying Therapies (DMT) in Patients With Multiple Sclerosis: an Interview Based Study Among Patients and Clinicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
ocrelizumab
Ocrevus
natalizumab
Tysabri
ofatumumab
Kesimpta
NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with MS and clinicians with experience treating MS from Germany, UK, and US

Brief summary: This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab


Eligibility criteria: Inclusion Criteria:

Patients who attend the following criteria will be included:

1. Age ≥18;
2. Current resident of the country of interest (i.e., Germany, the UK, or the US);
3. Relapsing-remitting MS diagnosis confirmed by a clinician;
4. Currently taking at least one of the following DMTs for MS after the maintenance phase: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®);
5. Two or more consecutive ocrelizumab doses (Six or more consecutive natalizumab doses or Six or more consecutive ofatumumab doses);
6. Follow the approved dosing regimen (Ocrelizumab: every six months or Natalizumab: every month or Ofatumumab: every month);
7. Experienced reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect);
8. Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate;
9. Able to read, understand, and communicate in English or German;
10. Willing and able to participate in a phone/web-based (remote) one-on-one interview, and to be audio-recorded;
11. Have an e-mail address and will have access to a computer or smartphone at the time of the interview to complete the electronic consent form.

Clinicians who attend the following criteria will be included:

1. Currently practices in one of the target countries (i.e., Germany, the UK, or the US);
2. Is a licensed clinician with a specialty in neurology;
3. Has prescribed at least one of the following DMTs within the last year: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®);
4. Has treated at least 16 MS patients within the last month;
5. Is personally responsible for treatment decisions for their patients;
6. Has followed patients treating MS with any of the three DMTs for a. Two or more consecutive ocrelizumab doses or b. Six or more consecutive natalizumab doses. c. Six or more consecutive ofatumumab doses;
7. Has treated patients who have experienced specific reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect);
8. Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate;
9. Willing and able to participate in a phone/web-based interview, and to be audio-recorded.
10. Able to read, understand, and communicate in English

Exclusion Criteria:

Patients will be excluded from the enrollment if:

1. Has a diagnosis of clinically isolated MS syndrome, primary progressive MS, or secondary progressive MS;
2. Currently participates in an interventional MS clinical trial.

Clinicians will be excluded from the enrollment if are currently involved as a key opinion leader or receives funding from one of the drug manufacturers

Primary outcomes:
measure: Number of participants with key symptoms associated with the wearing off effect
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Secondary outcomes:
measure: Severity of wearing off effect symptoms
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
measure: Detailed language used to describe the experience of wearing off effect
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
measure: Number of participants switching from one therapy to another due to wearing off effect
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
measure: Number of participants who changed the dosing/infusion schedules due to wearing off effect
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
measure: Dissimilarities of clinician' and patients' views of wearing off effect
timeFrame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: