Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS (SEP-RR)
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|ClinicalTrials.gov Identifier: NCT04838015|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 13, 2021
Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system.
The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria.
Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy.
Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.
The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS.
The secondary objective is the search of predictive factors of response to treatment.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS|
|Actual Study Start Date :||November 13, 2020|
|Estimated Primary Completion Date :||November 13, 2021|
|Estimated Study Completion Date :||November 13, 2021|
- Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis [ Time Frame: Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined] ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838015
|Contact: Nicolas COLLONGUES, MD||33 3 88 12 87 email@example.com|
|Contact: Saïd CHAYER, PhD, HDR||33 3 88 11 66 firstname.lastname@example.org|
|Hautepierre Clinical Investigation Center - Strasbourg University Hospitals||Recruiting|
|Strasbourg, France, 67091|
|Contact: Nicolas COLLONGUES, MD 33 3 88 12 87 33 email@example.com|
|Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 firstname.lastname@example.org|
|Principal Investigator: Nicolas COLLONGUES, MD|
|Sub-Investigator: Margaux TIBERI, MD|
|Sub-Investigator: Kévin BIGAUT, MD|
|Sub-Investigator: Nicolas MEYER, MD, PhD|
|Sub-Investigator: Guillaume MATHEY, MD|