Clinical trial • Not applicable • Neurology

Ocrelizumab for Neurological disorder | Multiple sclerosis

Not applicable trial of Ocrelizumab for Neurological disorder | Multiple sclerosis. open-label, none/not specified-controlled. 142 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Neurological disorder | Multiple sclerosis
Trial Stage
Not applicable
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
18-12-2023
First CTIS Authorization Date
23-04-2024

Trial design

open-label, none/not specified-controlled Not applicable trial across 24 sites in France, Germany, Czechia.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
142
Trial Duration For Participant
1825

Eligibility

Recruits 142 Vulnerable population selected. Requirement: "Signed extension study Informed Consent Form" — consent must be provided by the participant. No explicit details provided on assent, proxy consent, or age-specific consent documents or languages..

Pregnancy Exclusion
6. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
Vulnerable Population
Vulnerable population selected. Requirement: "Signed extension study Informed Consent Form" — consent must be provided by the participant. No explicit details provided on assent, proxy consent, or age-specific consent documents or languages.

Inclusion criteria

  • {"criterion_text":"- 1. Signed extension study Informed Consent Form\n- 2. Eligible for continuing on Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol\n- 3. First dose of study treatment in this extension study will be received within the treatment window allowed by the parent study.\n- 4. Continue to benefit from the Roche active substance at the time of roll-over from the parent study as assessed by the investigator\n- 5. Ability to comply with the extension study protocol, per investigator’s judgement\n- 6. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential"}

Exclusion criteria

  • {"criterion_text":"- 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study\n- 2. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient\n- 3. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient\n- 4. Treatment with any other neurological treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study\n- 5. Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)\n- 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Not available","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- N/A","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
142
Recruitment Window Months
59
Consent Approach
Signed extension study Informed Consent Form required; consent provided by the participant. No details provided on assent, proxy consent, age-specific documents, or available languages.

Geography

Total Number Of Sites
24
Total Number Of Participants
196

France

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
68
Number Of Sites
12
Number Of Participants
69

Sites

Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service neurologie
Contact Person Name
Pierre BRANGER
Contact Person Email
branger-p@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service neurologie
Contact Person Name
Pierre Labauge
Contact Person Email
p-labauge@chu-montpellier.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service neurologie
Contact Person Name
Patricia Bernady
Contact Person Email
pbernady@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service neurologie
Contact Person Name
Patrick Vermersch
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service neurologie
Contact Person Name
Laure MICHEL
Contact Person Email
laure.michel@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service neurologie
Contact Person Name
Abdullatif AL KHEDR
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service neurologie
Contact Person Name
Christine Lebrun-Frenay
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service neurologie
Contact Person Name
Jérôme de Seze
Site Name
Hospices Civils De Lyon
Department Name
Service neurologie
Contact Person Name
Sandra VUKUSIC
Contact Person Email
sandra.vukusic@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service neurologie
Contact Person Name
Aurélie RUET
Contact Person Email
aurelie.ruet@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service neurologie
Contact Person Name
Giovanni CASTELNOVO
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service neurologie
Contact Person Name
Pierre CLAVELOU

Germany

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
36
Number Of Sites
4
Number Of Participants
37

Sites

Site Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Department Name
-
Contact Person Name
Daniela Rau
Contact Person Email
rau@neurologie-ulm.de
Site Name
DKD HELIOS Klinik Wiesbaden GmbH
Department Name
Neurologie
Contact Person Name
Ann-Sophie Lauenstein
Site Name
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Department Name
Studienzentrum Nordwest
Contact Person Name
Wolfgang Schwarz
Site Name
Technische Universitat Dresden
Department Name
Neurologische Uniklinik
Contact Person Name
Tjalf Ziemssen

Czechia

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
33
Number Of Sites
8
Number Of Participants
90

Sites

Site Name
Krajska zdravotni a.s.
Department Name
Neurology
Contact Person Name
Marta Vachová
Contact Person Email
marta.vachova@kzcr.eu
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurology
Contact Person Name
Eva Krasulová
Contact Person Email
eva.krasulova@vfn.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurology
Contact Person Name
Miroslav Mareš
Contact Person Email
miroslav.mares@nempk.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurology
Contact Person Name
Zbyšek Pavelek
Contact Person Email
zbysek.pavelek@fnhk.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Neurology
Contact Person Name
Michal Dufek
Contact Person Email
michal.dufek@fnusa.cz
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
Neurology
Contact Person Name
Ondřej Škoda
Contact Person Email
skodao@nemji.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurology
Contact Person Name
Pavel Hradílek
Contact Person Email
pavel.hradilek@fno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Neurology
Contact Person Name
Jana Libertínová
Contact Person Email
studie@fnmotol.cz

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Parexel International Limited
Responsibilities
sponsorDuties code 6
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties code 3

Third parties

  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ocrevus
Active Substance
Ocrelizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorized (prodAuthStatus=1)
Maximum Dose
920 mg
Investigational Product Name
Ocrelizumab
Active Substance
Ocrelizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Authorized (prodAuthStatus=1)
Maximum Dose
600 mg
Combination Treatment
Yes

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