The 'Wearing Off' Effect of DMT

Study Overview
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Brief Summary
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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

Official Title
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Understanding the 'Wearing Off' Effect From Disease-modifying Therapies (DMT) in Patients With Multiple Sclerosis: an Interview Based Study Among Patients and Clinicians

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: ocrelizumab
* Other: natalizumab
* Other: ofatumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who attend the following criteria will be included: Age ≥18; Current resident of the country of interest (i.e., Germany, the UK, or the US); Relapsing-remitting MS diagnosis confirmed by a clinician; Currently taking at least one of the following DMTs for MS after the maintenance phase: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®); Two or more consecutive ocrelizumab doses (Six or more consecutive natalizumab doses or Six or more consecutive ofatumumab doses); Follow the approved dosing regimen (Ocrelizumab: every six months or Natalizumab: every month or Ofatumumab: every month); Experienced reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect); Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate; Able to read, understand, and communicate in English or German; Willing and able to participate in a phone/web-based (remote) one-on-one interview, and to be audio-recorded; 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: Currently practices in one of the target countries (i.e., Germany, the UK, or the US); Is a licensed clinician with a specialty in neurology; Has prescribed at least one of the following DMTs within the last year: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®); Has treated at least 16 MS patients within the last month; Is personally responsible for treatment decisions for their patients; 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; Has treated patients who have experienced specific reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect); Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate; Willing and able to participate in a phone/web-based interview, and to be audio-recorded. Able to read, understand, and communicate in English Exclusion Criteria: Patients will be excluded from the enrollment if: Has a diagnosis of clinically isolated MS syndrome, primary progressive MS, or secondary progressive MS; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ocrelizumab<br>patients prescribed with ocrelizumab | Other: ocrelizumab<br>* Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.<br>* Other names: Ocrevus;|
| natalizumab<br>Patients prescribed with natalizumab | Other: natalizumab<br>* Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.<br>* Other names: Tysabri;|
| ofatumumab<br>Patients prescribed with ofatumumab | Other: ofatumumab<br>* Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.<br>* Other names: Kesimpta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with key symptoms associated with the wearing off effect | Number of participants with the following recurring symptoms will be collected: Fatigue Physical Pain Mobility issues or walking difficulties Numbness or sensory issues Cognitive difficulties Weakness Spasms Balance disturbance or dizziness Blurry vision or visual impairment Others | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of wearing off effect symptoms | Based on qualitative score rating | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 
| Detailed language used to describe the experience of wearing off effect | Terms used to describe times when patients MS gets better and when it gets worse will be collected. | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 
| Number of participants switching from one therapy to another due to wearing off effect | Number of participants switching from one therapy to another due to wearing off effect will be collected | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 
| Number of participants who changed the dosing/infusion schedules due to wearing off effect | Number of participants who changed the dosing/infusion schedules due to wearing off effect will be collected | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 
| Dissimilarities of clinician' and patients' views of wearing off effect | Assessed qualitatively via concept coding techniques | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIS, Multiple Sclerosis, MS, ocrelizumab, Ocrevus, natalizumab, Tysabri, ofatumumab, Kesimpta