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A study to evaluate specific unmet needs in the current clinical practice of multiple sclerosis
Evaluation of specific unmet needs in the current clinical practice of multiple sclerosis: characterization of different profiles of relapsing multiple sclerosis patients defined by disease activity and patient-reported outcomes (Profile RMS)
Autoimmune Disorder Multiple Sclerosis (MS)
Basic Details
Both
≥ 18 Years
No
Sponsor
Roche Pharma AG (Germany)
Study Identifier
ML39348
Who can participate?
People over 18 years of age with RMS (RRMS and rSPMS)
What does the study involve?
Participants may be asked to be in the study for up to 12 months. This includes:
A screening period where participants will be assessed for eligibility to participate in the study and further into the following subgroups:
Subgroup 1 will include participants with MS who have been on DMT for the past 12 months.
Subgroup 2 will include participants with MS who have experienced significant side effects with DMTs.
Subgroup 3 will include participants with MS who have low treatment satisfaction.
Subgroup 4 will include participants with MS who have never received any treatment for the disease.
Subgroup 5 will include participants with MS who are without treatment currently but had been previously treated with a DMT.
During the observation period three visits are recorded by the study doctor in a standardised form either on paper or electronically. The first visit will be the baseline and the second and the third observation visits should take place around 6 and 12 months (±2 weeks) after the baseline visit.
During clinic visits, participants will be assessed for various parameters such as progression of the disease, treatment satisfaction, extent of disability, frequency of relapses, overall disease status, and so forth. Assessments will be made using patient questionnaires, lab tests, MRI scans, etc.
What are the possible benefits and risks of participating?
Participants will not receive any benefit from participating in this study, but the information that is learned from this study may help researchers and doctors to learn more about MS in general and other people who have a similar medical condition may benefit from the results of such research in the future. There are no risks from participating in the study.
Where is the study run from?
Roche Pharma AG (Germany)
When is the study starting and how long is it expected to run for?
November 2016 to September 2023
Who is funding the study?
Roche Pharma AG (Germany)
Who is the main contact?
[email protected]
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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For the latest version of this information please go to www.forpatients.roche.com