Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS (SEP-RR)

April 8, 2021 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Hautepierre Clinical Investigation Center - Strasbourg University Hospitals
        • Contact:
        • Principal Investigator:
          • Nicolas Collongues, MD
        • Sub-Investigator:
          • Margaux TIBERI, MD
        • Sub-Investigator:
          • Kévin BIGAUT, MD
        • Sub-Investigator:
          • Guillaume MATHEY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major subject Suffering from relapsing-remitting MS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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]
Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2020

Primary Completion (ANTICIPATED)

November 13, 2021

Study Completion (ANTICIPATED)

November 13, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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