Multiple SclerosisSEP-RRNCT04838015
Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS
An observational study of Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2020to 13 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject Suffering from relapsing-remitting MS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hautepierre Clinical Investigation Center - Strasbourg University Hospitals
Strasbourg, 67091
Nicolas COLLONGUES, MD, 33 3 88 12 87 33, nicolas.collongues@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
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.
Read more
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
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis
Measured: Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start13 Nov 2020
- Primary completion13 Nov 2021 (estimated)
- Study completion13 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838015
- Sponsor's protocol ID
- 8037
- Acronym
- SEP-RR
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS
- ClinicalTrials.gov ID
- NCT04838015
- Acronym / sponsor ID
- SEP-RR / 8037
- Conditions
- Multiple Sclerosis
- Keywords
- MS-RR, Ocrelizumab, Switch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 13 Nov 2021 (estimated)
- Study completion
- 13 Nov 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject Suffering from relapsing-remitting MS
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Related trials for Multiple Sclerosis
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas COLLONGUES, MD (33 3 88 12 87 33, nicolas.collongues@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.