The 'Wearing Off' Effect of DMT

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: ocrelizumab; Other: natalizumab; Other: ofatumumab

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with MS and clinicians with experience treating MS from Germany, UK, and US

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ocrelizumab; patients prescribed with ocrelizumab	Other: ocrelizumab; 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.; Other Names: Ocrevus
natalizumab; Patients prescribed with natalizumab	Other: natalizumab; 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.; Other Names: Tysabri
ofatumumab; Patients prescribed with ofatumumab	Other: ofatumumab; 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.; Other Names: Kesimpta

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; MS; ofatumumab; ocrelizumab; Ocrevus; natalizumab; Tysabri; Kesimpta; NIS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Ofatumumab; Ocrelizumab; Natalizumab
• Other Study ID Numbers: COMB157G2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No