The 'Wearing Off' Effect of DMT

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: natalizumab; Other: ocrelizumab; Other: ofatumumab

• Registration Number: NCT05627271
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-25
• Study Start: 2023-01-10
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
natalizumab	natalizumab	Patients prescribed with natalizumab
ocrelizumab	ocrelizumab	patients prescribed with ocrelizumab
ofatumumab	ofatumumab	Patients prescribed with ofatumumab

Primary Outcome Measures

Name	Time	Method
Number of participants with key symptoms associated with the wearing off effect	Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Basel, Switzerland