Clinical trial • Neurology

OCRELIZUMAB for Multiple sclerosis

Clinical trial of OCRELIZUMAB for Multiple sclerosis. open-label, none/not specified-controlled. 142 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Multiple sclerosis
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
07-08-2024
First CTIS Authorization Date
22-11-2024

Trial design

open-label, none/not specified-controlled trial in France, Germany, Bulgaria.

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

Eligibility

Recruits 142 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is required: 'Signed extension study Informed Consent Form' is an inclusion criterion. Subject information and informed consent form documents are provided (country-specific versions present). Consent is provided by the participant; there is no mention of assent procedures for minors..

Pregnancy Exclusion
5. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is required: 'Signed extension study Informed Consent Form' is an inclusion criterion. Subject information and informed consent form documents are provided (country-specific versions present). Consent is provided by the participant; there is no mention of assent procedures for minors.

Inclusion criteria

  • {"criterion_text":"- 1. Signed extension study Informed Consent Form\n- 2. Patients who were on ongoing ocrelizumab treatment on one of the following parent studies (Studies MN39159/CONSONANCE, BN42082/MUSETTE, BN42083/GAVOTTE, BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O’HAND, MN43964/OLERO, GN41791/FENTREPID, BP46016/ MINTAKA, CN41144/OCARINA I-SC, CN42097/OCARINA II-SC) at the time of roll-over and who do not have access to the ocrelizumab treatment locally\n- 3. The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study\n- 4. Ability to comply with the extension study protocol, per investigator’s judgement\n- 5. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential\n- 6. Requirements for contraception and pregnancy testing For female participants of childbearing potential: : agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab Participants are considered to be of childbearing potential if they are postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements As defined by the guidelines, the following contraceptive methods are considered acceptable: (1) Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; (2) Male or female condom with or without spermicide; (3) Cap, diaphragm, or sponge with spermicide; (4) Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier method) Birth control methods that are highly effective (i.e., failure rate <1%) may also be used but are not required, and include: (1) Oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation. (2) Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation. (3) Intrauterine device. (4) Intrauterinehormone-releasing system. (5) Bilateral tubal occlusion. (6) Vasectomized partner. (7) Sexual abstinence"}

Exclusion criteria

  • {"criterion_text":"- 1. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient\n- 2. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient\n- 3. Permanent premature 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- 4. 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\n- 5. Concurrent participation in any therapeutic clinical trial (other than the parent study)\n- 6. Hypersensitivity to the active substance"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Change from baseline to end of study in Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)\n- 2. Number of eligible participants who have received access to ocrelizumab in the study (time frame: up to 5 years)","definition_or_measurement_approach":"1. Measured as change from baseline to end of study in PROMISnq PFMS-15a score.\n2. Count of eligible participants who have received access to ocrelizumab within the study; time frame specified as up to 5 years."}

Secondary endpoints

  • {"endpoint_text":"- 1. The incidence, nature, severity and outcome of serious adverse events, adverse events leading to discontinuation, and adverse events of special interest","definition_or_measurement_approach":"Measured as incidence and characterization (nature, severity, outcome) of SAEs, AEs leading to discontinuation, and AEs of special interest during the study period."}

Recruitment

Planned Sample Size
142
Recruitment Window Months
57
Consent Approach
Participants must provide a signed extension study Informed Consent Form. Subject information and informed consent form documents are present (country-specific versions). Consent is provided by the participant; no assent for minors is described. Consent documents available in multiple languages (documents listed include ENG, FR, BG, DEU versions).

Geography

Total Number Of Sites
25
Total Number Of Participants
136

France

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
515
Number Of Sites
17
Number Of Participants
69

Sites

Site Name
CHRU De Nancy
Department Name
Service neurologie
Principal Investigator Name
Guillaume Matthey
Principal Investigator Email
g.mathey@chru-nancy.fr
Contact Person Name
Guillaume Matthey
Contact Person Email
g.mathey@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service neurologie
Principal Investigator Name
Christine Lebrun-Frenay
Principal Investigator Email
recherche-clinique-neurologie@chu-nice.fr
Contact Person Name
Christine Lebrun-Frenay
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service neurologie
Principal Investigator Name
David Laplaud
Principal Investigator Email
david.laplaud@chu-nantes.fr
Contact Person Name
David Laplaud
Contact Person Email
david.laplaud@chu-nantes.fr
Site Name
CHU Besancon
Department Name
Service neurologie
Principal Investigator Name
Eric Berger
Principal Investigator Email
eberger@chu-besancon.fr
Contact Person Name
Eric Berger
Contact Person Email
eberger@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service neurologie
Principal Investigator Name
Xavier Ayrignac
Principal Investigator Email
x-ayrignac@chu-montpellier.fr
Contact Person Name
Xavier Ayrignac
Contact Person Email
x-ayrignac@chu-montpellier.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Service neurologie
Principal Investigator Name
Arnaud Kwiatkowski
Principal Investigator Email
kwiatkowski.arnaud@ghicl.net
Contact Person Name
Arnaud Kwiatkowski
Contact Person Email
kwiatkowski.arnaud@ghicl.net
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service neurologie
Principal Investigator Name
Aurore Jourdain
Principal Investigator Email
aurore.jourdain@chu-brest.fr
Contact Person Name
Aurore Jourdain
Contact Person Email
aurore.jourdain@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service neurologie
Principal Investigator Name
Aurélie RUET
Principal Investigator Email
aurelie.ruet@chu-bordeaux.fr
Contact Person Name
Aurélie RUET
Contact Person Email
aurelie.ruet@chu-bordeaux.fr
Site Name
Hospices Civils De Lyon
Department Name
Service neurologie
Principal Investigator Name
Sandra VUKUSIC
Principal Investigator Email
sandra.vukusic@chu-lyon.fr
Contact Person Name
Sandra VUKUSIC
Contact Person Email
sandra.vukusic@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service neurologie
Principal Investigator Name
Pierre BRANGER
Principal Investigator Email
branger-p@chu-caen.fr
Contact Person Name
Pierre BRANGER
Contact Person Email
branger-p@chu-caen.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service neurologie
Principal Investigator Name
Patricia Bernady
Principal Investigator Email
pbernady@ch-cotebasque.fr
Contact Person Name
Patricia Bernady
Contact Person Email
pbernady@ch-cotebasque.fr
Site Name
Centre Hospitalier Intercommunal De Poissy Saint Germain
Department Name
Service neurologie
Principal Investigator Name
Olivier Heinzlef
Principal Investigator Email
Olivier.Heinzlef@ght-yvelinesnord.fr
Contact Person Name
Olivier Heinzlef
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service neurologie
Principal Investigator Name
Abdullatif AL KHEDR
Principal Investigator Email
alkhedr.abdullatif@chu-amiens.fr
Contact Person Name
Abdullatif AL KHEDR
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service neurologie
Principal Investigator Name
Giovanni CASTELNOVO
Principal Investigator Email
giovanni.castelnovo@chu-nimes.fr
Contact Person Name
Giovanni CASTELNOVO
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service neurologie
Principal Investigator Name
Pierre CLAVELOU
Principal Investigator Email
pclavelou@chu-clermontferrand.fr
Contact Person Name
Pierre CLAVELOU
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service neurologie
Principal Investigator Name
Jérôme de Seze
Principal Investigator Email
Jerome.DESEZE@chru-strasbourg.fr
Contact Person Name
Jérôme de Seze
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service neurologie
Principal Investigator Name
Patrick Vermersch
Principal Investigator Email
patrick.vermersch@univ-lille2.fr
Contact Person Name
Patrick Vermersch

Germany

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
516
Number Of Sites
3
Number Of Participants
37

Sites

Site Name
DKD HELIOS Klinik Wiesbaden GmbH
Department Name
Neurologie
Principal Investigator Name
Ann-Sophie Lauenstein
Principal Investigator Email
ann-sophie.lauenstein@helios-gesundheit.de
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
Principal Investigator Name
Joachim Springub
Principal Investigator Email
dr.springub@t-online.de
Contact Person Name
Joachim Springub
Contact Person Email
dr.springub@t-online.de
Site Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Department Name
-
Principal Investigator Name
Daniela Rau
Principal Investigator Email
rau@neurologie-ulm.de
Contact Person Name
Daniela Rau
Contact Person Email
rau@neurologie-ulm.de

Bulgaria

Earliest CTIS Part Ii Submission Date
19-11-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
162
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurological clinic - nervous diseases
Principal Investigator Name
Maya Danovska-Mladenova
Principal Investigator Email
mdanovska@yahoo.com
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Department Name
Neurological clinic - nervous diseases
Principal Investigator Name
Dimitar Maslarov
Principal Investigator Email
maslarovd@abv.bg
Contact Person Name
Dimitar Maslarov
Contact Person Email
maslarovd@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Avis Medika OOD
Department Name
Neurological clinic - nervous diseases
Principal Investigator Name
Hristo Lilovski
Principal Investigator Email
lillovski@abv.bg
Contact Person Name
Hristo Lilovski
Contact Person Email
lillovski@abv.bg
Site Name
Military Medical Academy
Department Name
Neurological clinic - nervous diseases
Principal Investigator Name
Hristina Dimitrova
Principal Investigator Email
drhrisi@abv.bg
Contact Person Name
Hristina Dimitrova
Contact Person Email
drhrisi@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Multiple sclerosis department at the clinic for nervous diseases for movement disorders
Principal Investigator Name
Ivan Milanov
Principal Investigator Email
bostro@abv.bg
Contact Person Name
Ivan Milanov
Contact Person Email
bostro@abv.bg

Sponsor

Primary sponsor

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

Contract research organisations

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

Third parties

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

Investigational products

Investigational Product Name
Ocrevus 300 mg concentrate for solution for infusion
Active Substance
OCRELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
marketingAuthNumber: EU/1/17/1231/001
Maximum Dose
600 mg (maxDailyDoseAmount)
Investigational Product Name
Ocrevus 920 mg solution for injection
Active Substance
OCRELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
marketingAuthNumber: EU/1/17/1231/003
Maximum Dose
920 mg (maxDailyDoseAmount)

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