Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04838015

Acronym

SEP-RR

Enrollment

250

Registered

2021-04-08

Start date

2020-11-13

Completion date

2021-11-13

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

MS-RR, Ocrelizumab, Switch

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Major subject (≥18 years old) * Suffering from relapsing-remitting MS (RRMS) * Supported in a neurology department at Strasbourg or Nancy University Hospital between 10/01/2018 and 11/31/2020. * Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020. * Have had an M0, M3 / M6 and M12 MRI after initiation of treatment. * Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion criteria

* Subject having expressed opposition to participating in the study * Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP) * Subject not meeting all the inclusion criteria * Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) * Subjects under safeguard of justice * Subject under guardianship or guardianship

Design outcomes

Primary

Measure	Time frame
Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis	Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined]

Countries

France

Contacts

Primary ContactNicolas COLLONGUES, MD

nicolas.collongues@chru-strasbourg.fr33 3 88 12 87 33

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr33 3 88 11 66 90

Outcome results