Clinical trial • Phase IV • Neurology

ocrelizumab for Progressive multiple sclerosis

Phase IV trial of ocrelizumab for Progressive multiple sclerosis. 89 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Progressive multiple sclerosis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
26-08-2024
First CTIS Authorization Date
19-09-2024

Trial design

Phase IV trial across 15 sites in France.

Target Sample Size
89

Eligibility

Recruits 89 No vulnerable population selected; no consent or assent information provided in the record..

Vulnerable Population
No vulnerable population selected; no consent or assent information provided in the record.

Recruitment

Planned Sample Size
89
Recruitment Window Months
54

Geography

Total Number Of Sites
15
Total Number Of Participants
89

France

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
386
Number Of Sites
15
Number Of Participants
89

Sites

Site Name
CHRU De Nancy
Department Name
neurology
Contact Person Name
guillaume Mathey
Contact Person Email
gmathey@chru-nancy.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neuropogy
Contact Person Name
jerome De Seze
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurology
Contact Person Name
Christine LEBRUN-FRENAY
Contact Person Email
lebrun-frenay.c@chu-nice.fr
Site Name
CHU Amiens - Groupe Hospitalier Sud
Department Name
Neurology
Contact Person Name
Abdullatif AL KHEDR
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Neurology
Contact Person Name
Laure Michel
Contact Person Email
Laure.michel@chu-rennes.fr
Site Name
CHU Gabriel-Montpied
Department Name
Neurology
Contact Person Name
Pierre Clavelou
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurology
Contact Person Name
Aurelie Ruet
Contact Person Email
aurelie.ruet@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurology
Contact Person Name
Patrick Vermersch
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Neurology
Contact Person Name
Jean Pelletier
Contact Person Email
Jean.PELLETIER@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Neurology
Contact Person Name
Sandra Vukusic
Contact Person Email
sandra.vukusic@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Neurology
Contact Person Name
Pierre Branger
Contact Person Email
branger-p@chu-caen.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
neurology
Contact Person Name
Patricia Brnardy
Contact Person Email
pbernady@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Neurology
Contact Person Name
Giovanni Castelnovo
Site Name
CHU de Nantes - Hôpital Laennec
Department Name
Neurology
Contact Person Name
David Laplaud
Contact Person Email
david.laplaud@univ-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Neurology
Contact Person Name
Pierre Labauge
Contact Person Email
labauge@yahoo.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Nice
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Ocrelizumab
Active Substance
ocrelizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous

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