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

NCT04838015 | Unknown

• 1 other identifier: 8037
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

MS-RR; Ocrelizumab; Switch

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major subject Suffering from relapsing-remitting MS

You may qualify if:

• 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

You may not qualify if:

• Subject having expressed opposition to participating in the study
• Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP)
• Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
• Subjects under safeguard of justice
• Subject under guardianship or guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hautepierre Clinical Investigation Center - Strasbourg University Hospitals

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nicolas COLLONGUES, MD

CONTACT

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

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90; said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: April 8, 2021
• Study Start: November 13, 2020
• Primary Completion: November 13, 2021
• Study Completion: November 13, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-02

Locations

FR (1)