The 'Wearing Off' Effect of DMT

NCT05627271 | Completed

• 1 other identifier: COMB157G2012
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple Sclerosis; MS; ocrelizumab; Ocrevus; natalizumab; Tysabri; ofatumumab; Kesimpta; NIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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 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

• 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

Study Arms (3)

ocrelizumab

patients prescribed with ocrelizumab

Other: ocrelizumab

natalizumab

Patients prescribed with natalizumab

Other: natalizumab

ofatumumab

Patients prescribed with ofatumumab

Other: ofatumumab

Interventions

ocrelizumab 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.

Also known as: Ocrevus

ocrelizumab

natalizumab 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.

Also known as: Tysabri

natalizumab

ofatumumab 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.

Also known as: Kesimpta

ofatumumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Basel, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab; Natalizumab; ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 25, 2022
• Study Start: January 10, 2023
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)