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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease
Multiple Sclerosis

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab




Primary Outcome Measures :
  1. 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] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Major subject Suffering from relapsing-remitting MS
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Nicolas COLLONGUES, MD 33 3 88 12 87 33 nicolas.collongues@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 said.chayer@chru-strasbourg.fr

Locations
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France
Hautepierre Clinical Investigation Center - Strasbourg University Hospitals Recruiting
Strasbourg, France, 67091
Contact: Nicolas COLLONGUES, MD    33 3 88 12 87 33    nicolas.collongues@chru-strasbourg.fr   
Contact: Saïd CHAYER, PhD, HDR    33 3 88 11 66 90    said.chayer@chru-strasbourg.fr   
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04838015    
Other Study ID Numbers: 8037
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
MS-RR
Ocrelizumab
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Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases