The 'Wearing Off' Effect of DMT

NCT ID: NCT05627271

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-04-20

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

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ocrelizumab

patients prescribed with ocrelizumab

ocrelizumab

Intervention Type: OTHER

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.

natalizumab

Patients prescribed with natalizumab

natalizumab

Intervention Type: OTHER

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.

ofatumumab

Patients prescribed with ofatumumab

ofatumumab

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Ocrevus; Tysabri; Kesimpta

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

COMB157G2012

Identifier Type: -

Identifier Source: org_study_id