Clinical trial • Phase III • Neurology

Ocrelizumab for Relapsing-remitting multiple sclerosis

Phase III trial of Ocrelizumab for Relapsing-remitting multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Relapsing-remitting multiple sclerosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
07-11-2024
First CTIS Authorization Date
18-03-2025

Trial design

Randomised, fda-licensed ocrelizumab and eu-approved ocrelizumab (ocrevus 300 mg concentrate for solution for infusion) — same dose as abp 692 as stated; specific dose amount and dosing schedule not specified in the record.-controlled Phase III trial in Croatia, Slovenia, Bulgaria and others.

Randomised
Yes
Comparator
FDA-licensed ocrelizumab and EU-approved ocrelizumab (Ocrevus 300 mg concentrate for solution for infusion) — same dose as ABP 692 as stated; specific dose amount and dosing schedule not specified in the record.
Target Sample Size
444
Trial Duration For Participant
336

Eligibility

Recruits 444 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is from adult subjects (study population 18 to 60 years). Subject information and informed consent form (ICF) documents are provided (multiple country/language versions and PK/main group versions); pregnancy follow-up and partner information documents are available. No assent process for minors is indicated..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is from adult subjects (study population 18 to 60 years). Subject information and informed consent form (ICF) documents are provided (multiple country/language versions and PK/main group versions); pregnancy follow-up and partner information documents are available. No assent process for minors is indicated.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017."}
  • {"criterion_text":"- Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive."}
  • {"criterion_text":"- Evidence of recent MS activity as defined by the study protocol."}
  • {"criterion_text":"- Neurologically stable subject, with no relapse for ≤ 28 days before randomization."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of PPMS according to the 2017 revision of the McDonald diagnostic criteria or with secondary progressive MS (Thompson et al, 2018)."}
  • {"criterion_text":"- Multiple sclerosis disease duration of ≥ 10 years in subjects with EDSS score of ≤ 2.5 at screening."}
  • {"criterion_text":"- Any contraindications to study procedures or medications as outlined in the study protocol."}
  • {"criterion_text":"- Any prohibited medication as defined in the study protocol."}
  • {"criterion_text":"- Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study."}
  • {"criterion_text":"- Current or history of any medical conditions described in the study protocol."}
  • {"criterion_text":"- Any abnormal laboratory blood values as defined in the study protocol."}
  • {"criterion_text":"- Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Area under the serum concentration-time curve (AUC) from time 0 to day 15 (AUC0-d15) following infusion 1 of the initial dose","definition_or_measurement_approach":"AUC of serum concentration-time curve from time 0 to day 15 following infusion 1 (measured from blood serum concentrations over time)."}
  • {"endpoint_text":"- AUC from time 0 extrapolated to infinity (AUC0-inf) of the entire initial dose","definition_or_measurement_approach":"AUC of serum concentration-time curve from time 0 extrapolated to infinity for the entire initial dose (pharmacokinetic assessment from serum samples, extrapolation to infinity)."}
  • {"endpoint_text":"- Total number of new GdE T1-weighted lesions (assessed by brain MRI) over weeks 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Number of new gadolinium-enhancing (GdE) T1-weighted brain MRI lesions counted at scheduled MRI assessments at weeks 4, 8, 12, 16, 20 and 24 (assessed by brain MRI)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
444
Recruitment Window Months
28
Consent Approach
Informed consent obtained from adult subjects (18–60 years). Multiple ICF documents are provided (main group, PK group, pregnancy follow-up, country-specific versions) in multiple languages (examples in the documents: English, Slovenian, Bulgarian, Czech, Slovak, Spanish, French, Polish, Romanian, Dutch, Catalan and others). No assent for minors is indicated.

Methods

  • Site-based recruitment using study-site materials (site brochures, flyers, posters, site biosimilar infographics) as listed in recruitment documents.
  • Patient-facing materials: patient brochures, patient letters, patient leaflets and study brochures (country-specific language versions available).
  • Recruitment advertising statements and recruitment arrangements documents intended for publication (country-specific).
  • In-clinic engagement including GP letters and subject cards provided to potential participants.
  • ICF flipbooks and informed consent materials delivered at sites (paper/print materials) and country-specific ICFs.

Geography

Total Number Of Sites
83
Total Number Of Participants
375

Croatia

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
206
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
University Hospital Centre Zagreb
Department Name
Neurology Department
Contact Person Name
Mario Habek
Contact Person Email
mhabek@mef.hr
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Neurology Department
Contact Person Name
Lidija Dezmalj Grbelja
Contact Person Email
lidija.dezmalj@kbcsm.hr

Slovenia

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
63
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
UNIVERZITETNI KLINICNI CENTER MARIBOR
Department Name
Department of neurology
Contact Person Name
Jožef Magdič
Contact Person Email
jozef.magdic@ukc-mb.si
Site Name
University Medical Center Ljubljana
Department Name
Department of neurology
Contact Person Name
Gregor Brecl Jakob
Contact Person Email
gregor.brecljakob@kclj.si

Bulgaria

Earliest CTIS Part Ii Submission Date
18-02-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
273
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurological Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Krasimir Genov
Contact Person Email
Kr_genov@abv.bg
Site Name
Medical Center Hera EOOD
Contact Person Name
Plamen Antimov
Contact Person Email
Plamen.antimov@gmail
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Neurology
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Neurology
Contact Person Name
Penko Shotekov
Contact Person Email
shotekov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Neurology
Contact Person Name
Ivan Milanov
Contact Person Email
milanovivan54@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
430
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Noorderhart
Department Name
Neurology
Contact Person Name
Cornelia Rogojan
Site Name
Algemeen Ziekenhuis Delta
Department Name
Neurology
Contact Person Name
Maarten Buyle
Contact Person Email
maarten.buyle@azdelta.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Neurology
Contact Person Name
Barbara Willekens
Contact Person Email
barbara.willekens@uza.be

Sweden

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
427
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
MS Centrum Forskningsenhet
Contact Person Name
Lenka Nováková Nyrén
Site Name
Karolinska University Hospital
Department Name
ME Neurologi
Contact Person Name
Katharina Fink

Czechia

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
433
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. neurologicka klinika
Contact Person Name
Michal Dufek
Contact Person Email
michal.dufek@fnusa.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologicka klinika
Contact Person Name
Zbyšek Pavelek
Contact Person Email
zbysek.pavelek@fnhk.cz
Site Name
Krajska zdravotni a.s.
Department Name
MS centrum pri neurologickem oddeleni
Contact Person Name
Marta Vachová
Contact Person Email
marta.vachova@kzcr.eu
Site Name
Neurologie Rs Centrum s.r.o.
Department Name
Nestatni zdravotnicke zarizeni, Privatni ordinace neurologie
Contact Person Name
Radomír Taláb
Contact Person Email
radomir.talab@gmail.com
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
Neurologicke oddeleni
Contact Person Name
Radek Ampapa
Contact Person Email
ampapar@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
426
Number Of Sites
13
Number Of Participants
32

Sites

Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurology
Contact Person Name
Lamberto Landete Pascual
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Contact Person Name
Maria Luisa Martinez Gines
Contact Person Email
marisamgines@hotmail.com
Site Name
Hospital Universitario De Torrejon
Department Name
Neurology
Contact Person Name
Luis Ignacio Casanova Peño
Contact Person Email
licasanova@torrejonsalud.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Francisco Carlos Perez Miralles
Contact Person Email
perez_fca@gva.es
Site Name
Hospital Santa Caterina Ias
Department Name
Neurology
Contact Person Name
Gary Álvarez Bravo
Contact Person Email
galvarez@idibgi.org
Site Name
Hospital Alvaro Cunqueiro
Department Name
Neurology
Contact Person Name
Ines Gonzalez-Suarez
Contact Person Email
igonsua@gmail.com
Site Name
Hospital Vithas Parque San Antonio
Department Name
Neurology
Contact Person Name
Nicolas Lundahi Ciano Petersen
Contact Person Email
nico.edss.neuro@gmail.com
Site Name
Hospital De Denia
Department Name
Servicio de Neurología
Contact Person Name
Alexandre Garcia Escriva
Contact Person Email
agarescriva@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Sara Eichau Maueno
Contact Person Email
saraeichau@hotmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology
Contact Person Name
Yolanda Blanco Morgado
Contact Person Email
yblanco@clinic.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Ana Alonso Torres
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Neurology
Contact Person Name
Laura Borrega Canelo
Contact Person Email
laura.borrega@salud.madrid.org
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Neurology
Contact Person Name
Maria Dolores Paramo Camino
Contact Person Email
draparamo@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
05-03-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
415
Number Of Sites
14
Number Of Participants
150

Sites

Site Name
Neuro-Medic Sp. z o.o.
Department Name
Neuro-Medic Poradnia Wielospecjalistyczna
Contact Person Name
Janusz Zbrojkiewicz
Contact Person Email
neuromedic@op.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Department Name
Centrum Neurologii Klinicznej
Contact Person Name
Andrzej Szczudlik
Site Name
Vitamed Galaj I Cichomski Sp. j.
Department Name
NA/ND
Contact Person Name
Paweł Lisewski
Contact Person Email
r.cichomski@wp.pl
Site Name
Ilkowski I Partnerzy sp.p. Lekarzy
Department Name
NZOZ NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Contact Person Name
Jan Ilkowski
Contact Person Email
biuro@neurokard.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Department Name
NA/ND
Contact Person Name
Marcin Nastaj
Contact Person Email
marcinnastaj@gmail.com
Site Name
Mtz Clinical Research Powered By Pratia
Department Name
NA/ND
Contact Person Name
Małgorzata Zajda
Contact Person Email
info@pratia.com
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Department Name
NA / ND
Contact Person Name
Robert Bonek
Contact Person Email
r.bonek@ncbydgoszcz.pl
Site Name
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
Department Name
NA/ND
Contact Person Name
Adriana Chelminiak
Contact Person Email
neurologiczny.nzoz@gmail.com
Site Name
Centrum Neurologii Krzysztof Selmaj
Department Name
NA/ND
Contact Person Name
Krzysztof Selmaj
Site Name
Centrum Medyczne Neuroprotect
Department Name
NA/ND
Contact Person Name
Anna Karlinska
Contact Person Email
marta.biel@neuroprotect.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
SU w Krakowie, Zespol Poradni Specjalistycznych - Botaniczna 3, Poradnia Neurologiczna
Contact Person Name
Agnieszka Slowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Neuro-Care Sp. z o.o. sp.k.
Department Name
NA/ND
Contact Person Name
Gabriela Klodowska
Contact Person Email
neuro-care@neuro-care.pl
Site Name
Resmedica Sp. z o.o.
Department Name
Resmedica
Contact Person Name
Elzbieta Jasinska
Contact Person Email
ejasinska6@gmail.com
Site Name
Ma-Lek Clinical Sp. z o.o.
Department Name
Centrum Terapii SM
Contact Person Name
Maciej Maciejowski
Contact Person Email
m.m@ctsm.pl

Slovakia

Earliest CTIS Part Ii Submission Date
29-01-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
446
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
University Hospital Bratislava
Department Name
Neurologická klinika SZU Nemocnica Ružinov Ružinovská 6 826 06 Bratislava
Contact Person Name
Viera Hančinová
Contact Person Email
hancinova@pobox.sk
Site Name
EMPATHY s. r. o.
Department Name
Neurologická ambulancia EMPATHY s. r. o. Švabinského 17 85101 Bratislava
Contact Person Name
Soňa Feketová
Contact Person Email
empathy@gmail.com
Site Name
Fakultna Nemocnica Trnava
Department Name
Neurologická klinika
Contact Person Name
Georgi Krastev
Contact Person Email
georgi.krastev@fntt.sk

Denmark

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
427
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Danish Multiple Sclerosis Center
Contact Person Name
Tobias Sejbaek
Contact Person Email
tobias.sejbaek@rsyd.dk
Site Name
Aarhus University Hospital
Department Name
Department of Neurology
Contact Person Name
Kristina Svendsen
Contact Person Email
krissven@rm.dk
Site Name
Rigshospitalet
Department Name
Danish Multiple Sclerosis Center
Contact Person Name
Finn Sellebjerg
Contact Person Email
finn.sellebjerg@regionh.dk

Romania

Earliest CTIS Part Ii Submission Date
06-01-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
111
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Neurologie
Contact Person Name
Vitalie Vacaras
Site Name
Arensia Clinics S.R.L.
Department Name
Neurologie
Contact Person Name
Adina Maria Roceanu
Contact Person Email
adina.roceanu@arensia-em.com
Site Name
Spitalul Clinic Cai Ferate Constanta
Department Name
Neurologie
Contact Person Name
Ana Maria Ionescu
Contact Person Email
spunivcf_cta@yahoo.com
Site Name
Brainaxy Clinic S.R.L.
Department Name
Neurologie
Contact Person Name
Any Axelerad

Italy

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
430
Number Of Sites
9
Number Of Participants
28

Sites

Site Name
Careggi University Hospital
Department Name
SOD Neurologia II
Contact Person Name
Alice Mariottini
Contact Person Email
alice.mariottini@unifi.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
UOC Clinica Neurologica e Malattie Neurometaboliche
Contact Person Name
Nicola De Stefano
Contact Person Email
destefano@unisi.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Clinica Neurologica,Dip.to Scienze Mediche e Chirurgiche Avanzate
Contact Person Name
Antonio Gallo
Contact Person Email
antonio.gallo@unicampania.it
Site Name
Fondazione Istituto G. Giglio Di Cafalu
Department Name
Division of Neurology
Contact Person Name
Luigi Maria Grimaldi
Contact Person Email
luigi.grimaldi@hsrgiglio.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOSD Multiple Sclerosis Clinical and Research Center
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UO Riabilitazione Sclerosi Multipla
Contact Person Name
Francesco Ventruto
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Neurologia Azienda Ospedaliero-Universitaria Sant Andrea
Contact Person Name
Marco Salvetti
Contact Person Email
marco.salvetti@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Centro Sclerosi Multipla – Ambulatorio di Neuroriabilitazione
Contact Person Name
Francesco Patti
Contact Person Email
patti@unict.it
Site Name
Casa Di Cura Igea S.p.A.
Department Name
Dipartimento di Riabilitazione Igea
Contact Person Name
Annunziata Maria Letizia Leocani
Contact Person Email
l.leocani@casadicuraigea.it

Germany

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
419
Number Of Sites
13
Number Of Participants
41

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department of Neurology
Contact Person Name
Klemens Ruprecht
Site Name
Gemeinschaftpraxis Dres. Med Blersch/Redelstein
Department Name
Centre for Neurology
Contact Person Name
Wendelin Blersch
Contact Person Email
praxis@neuroamdom.de
Site Name
MultipEL Studies
Department Name
Institut für klinische Studien GbR
Contact Person Name
Birte Elias-Hamp
Site Name
Klinische Forschung Hamburg GmbH
Department Name
Center for Neurology
Contact Person Name
Christian Deckert
Contact Person Email
christian.deckert@pratia.com
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Neurology
Contact Person Name
Steffen Pfeuffer
Site Name
Universitaetsklinikum Essen AöR
Department Name
Clinic for Neurology
Contact Person Name
Refik Pul
Contact Person Email
refik.pul@uk-essen.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Department of Neurology MS Center
Contact Person Name
Tjalf Ziemssen
Site Name
ZNS GmbH Zentrum fuer Neuro-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
Department Name
Department of Neurology
Contact Person Name
Eugen Schlegel
Contact Person Email
schlegel@zns-siegen.de
Site Name
Neuropraxis Muenchen Sued
Department Name
Department of Neurology
Contact Person Name
Klaus Lehmann-Horn
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Department of Neurology
Contact Person Name
Florian Then Bergh
Site Name
Studienzentrum Dr. Bischof GmbH
Department Name
Department of Neurology
Contact Person Name
Felix Bischof
Contact Person Email
felix.bischof@me.com
Site Name
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Department Name
Centre for Neurology
Contact Person Name
Elvira Steidl
Contact Person Email
info@forschung-badhomburg.de
Site Name
curiositas ad sanum Studien und Beratungs GmbH
Department Name
Centre for Neurology
Contact Person Name
Johannes Schwarz

Lithuania

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
428
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Klaipedos universiteto ligonine VšĮ
Department Name
Neurology center
Contact Person Name
Lina Malciene
Contact Person Email
lina.malciene@kulig.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Neurology department
Contact Person Name
Renata Balnyte
Contact Person Email
renata.balnyte@lsmu.lt

France

Earliest CTIS Part Ii Submission Date
03-03-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
416
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service de Neurologie
Contact Person Name
Maximilien MOULIN
Contact Person Email
mmoulin@chu-reims.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service Neurologie
Contact Person Name
Eric Thouvenot
Contact Person Email
eric.thouvenot@chu-nimes.fr

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
ICON Clinical Research Limited
Name
ICON Clinical Research Limited Ireland Filial
Responsibilities
On site monitoring for Denmark only
Name
Icon Development Solutions LLC

Third parties

  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sample Storage for back-up samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"assay of ADA samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB (US/Canada)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Investigational product packaging, labeling and distribution","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"Patient Stipend","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"ICON Clinical Research Limited Ireland Filial","duties_or_roles":"On site monitoring for Denmark only","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Trulab Inc.","duties_or_roles":"Sample management and Tracking","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"In-home healthcare services to collect PK and ADA samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Teriflunomide test laboratory","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"CSI Clinical Services International GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ABP 692
Active Substance
Ocrelizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Not authorised (investigational product; prodAuthStatus: 1)
Investigational Product Name
Ocrevus 300 mg concentrate for solution for infusion
Active Substance
Ocrelizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present; prodAuthStatus: 2)
Starting Dose
300 mg (product name indicates 300 mg concentrate for solution for infusion)

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