The 'Wearing Off' Effect of DMT
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- ocrelizumab
- natalizumab
- ofatumumab
What it measured
Main measures
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
VisionThinking and memoryFatigueWalking and mobilitySpasticityPain
Other measures (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
Who could take part
Relapsing MS · 18 to 99
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
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History
Started
Jan 2023
Main results due
Apr 2023
Finished
Apr 2023
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