Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,919
Countries
20
Sites
106
Multiple Sclerosis (MS)
To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 23 Jun 2022 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-505974-14-00
- EudraCT number
- 2021-005746-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
Secondary objectives 1
- To evaluate the longer-term efficacy of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
Conditions and MedDRA coding
Multiple Sclerosis (MS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Single Arm This is a Phase IIIb, single-arm, multicenter, OLE study which will contribute to further
evaluation of the longer-term safety and efficacy of ocrelizumab in participants diagnosed with
relapsing MS (RMS) or primary progressive MS (PPMS). Participants who may benefit from
continued ocrelizumab treatment or are in safety follow-up will be enrolled in this extension
study of Studies WA21092 and WA21093 and WA25046.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
Exclusion criteria 2
- Concurrent participation in any clinical trial (other than the Parent study)
- Unable or unwilling to comply with the requirements of the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Secondary endpoints 4
- 1. Change in Expanded Disability Status Scale (EDSS) score over time
- 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time
- 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions
- 4. The change in total volume of T2 lesions and in total T1 lesion volume
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ocrevus 300 mg concentrate for solution for infusion
PRD5771848 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 10.20 g gram(s)
- Max treatment duration
- 417 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA36 — -
- Marketing authorisation
- EU/1/17/1231/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeled and re-packaged for clinical use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Unilabs A/S ORG-100032351
|
Copenhagen Oe, Denmark | Laboratory analysis |
| Neurostatus-UHB AG ORG-100046513
|
Basel, Switzerland | Other |
| Neurorx Research Inc. ORG-100046079
|
Montreal, Canada | Laboratory analysis |
Locations
20 EU/EEA countries · 106 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 10 | 3 |
| Belgium | Ongoing, recruitment ended | 21 | 5 |
| Bulgaria | Ongoing, recruitment ended | 25 | 7 |
| Croatia | Ongoing, recruitment ended | 14 | 2 |
| Czechia | Ongoing, recruitment ended | 83 | 8 |
| Estonia | Ongoing, recruitment ended | 7 | 2 |
| Finland | Ongoing, recruitment ended | 1 | 1 |
| France | Ongoing, recruitment ended | 40 | 10 |
| Germany | Ongoing, recruitment ended | 184 | 15 |
| Hungary | Ongoing, recruitment ended | 20 | 3 |
| Italy | Ongoing, recruitment ended | 103 | 11 |
| Latvia | Ongoing, recruitment ended | 6 | 2 |
| Lithuania | Ongoing, recruitment ended | 9 | 2 |
| Netherlands | Ongoing, recruitment ended | 6 | 1 |
| Poland | Ongoing, recruitment ended | 170 | 12 |
| Portugal | Ongoing, recruitment ended | 10 | 4 |
| Romania | Ongoing, recruitment ended | 1 | 1 |
| Slovakia | Ongoing, recruitment ended | 12 | 3 |
| Spain | Ongoing, recruitment ended | 78 | 11 |
| Sweden | Ongoing, recruitment ended | 9 | 3 |
| Rest of world
Brazil, Israel, Peru, Russian Federation, Ukraine, Tunisia, Serbia, Mexico, New Zealand, Australia, Canada, United States, Turkey, Switzerland, Argentina, United Kingdom, Belarus
|
— | 1,110 | — |
Investigational sites
Konvent Der Barmherzigen Brueder
Abteilung für Neurologie, Seilerstaette 2, 4020, Linz
Medical University Of Vienna
Universitätsklinik für Neurologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Universitätsklinik für Neurologie, Anichstrasse 35, 6020, Innsbruck
Algemeen Ziekenhuis Delta
Neurology, Deltalaan 1, 8800, Roeselare
Antwerp University Hospital
Neurology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az St-Jan Brugge-Oostende A.V.
Neurology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Alma
Neurology, Ringlaan 15, 9900, Eeklo
Military Medical Academy
Clinic of Neurology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Clinic of neurology diseases for movement disorders, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Clinic for intensive treatment of neurology diseases, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
Tokuda Hospital
Clinic of Neurology and Sleep Medicine, Bul. Nikola Yonkov Vaptsarov 51b, 1407, Sofia
MHAT National Heart Hospital EAD
Clinic of Neurology, Ulitsa Konyovitsa 65, 1309, Sofia
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
Clinic of Neurology, Bulevard Patriarh Evtimiy 37, 1142, Sofiya
Multiprofile Hospital For Active Treatment Avis Medika OOD
Department of Neurology, Ulitsa Kosta Hadzhipakev 7, 5801, Pleven
Opca Bolnica Varazdin
Neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin
KBC Zagreb
Neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Fakultni Nemocnice U Sv Anny V Brne
Neurology, Pekarska 53, Stare Brno, Brno-Stred
Fakultni Nemocnice Hradec Kralove
Neurology, Sokolska 581, 500 03, Novy Hradec Kralove
Krajska zdravotni a.s.
Neurology, Duchcovska 53, 415 01, Teplice
Fakultni Nemocnice Brno
Neurology, Jihlavska 340/20, Bohunice, Brno
Nemocnice Jihlava prispevkova organizace
Neurology, Vrchlickeho 4630/59, 586 01, Jihlava 1
Neurospol s.r.o.
Neurology, Kubinova 964/27, Hermanice, Slezska Ostrava
Nemocnice Pardubickeho kraje a.s.
Neurology, Kyjevska 44 Pardubicky, 530 03, Pardubice
Vseobecna Fakultni Nemocnice V Praze
Neurology, Katerinska 468/30, Nove Mesto, Prague 2
Tartu University Hospital
Neurology, A006, L. Puusepa Tn 8, Tartu Linn
Laane-Tallinna Keskhaigla AS
Neurology, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
Centre Hospitalier Universitaire De Bordeaux
Service de neurologie, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Nice
Services des neurosciences, 30 Voie Romaine, 06000, Nice
CHRU De Nancy
Service de neurologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Hospital Pierre Wertheimer
Service de neurologie, sclérose en plaques, pathologies de la myéline et neuroinflammation, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Intercommunal De Poissy Saint Germain
Service de neurologie, Residence Les Maisonnees, 10 Rue Du Champ Gaillard, Poissy
Centre Hospitalier Universitaire De Caen Normandie
Service de neurologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Nantes
Service de neurologie, CIC de neurologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Les Hopitaux Universitaires De Strasbourg
Service de neurologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Lille
Service de neurologie D, Rue Emile Laine, 59037, Lille Cedex
University Hospital Of Clermont-Ferrand
Service de neurologie, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Zentrum fuer ambulante Neurologie
Neurotransdata GmbH, Zentrum fuer ambulante Neurologie, Neurotransdata GmbH, Essen
Universitaet Leipzig
Klinik und Poliklinik fuer Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Studienzentrum Nord-West
NA, Kuhlenstr. 2, 26655, Westerstede
Universitaetsklinikum Duesseldorf AöR
Klinik fuer Neurologie, Moorenstrasse 5, Bilk, Duesseldorf
University Of Regensburg
Klinik und Poliklinik fuer Neurologie, Universitaetsstrasse 84, Kumpfmuehl-Ziegetsdorf-Neupruell, Regensburg
Charite Universitaetsmedizin Berlin KöR
Neurology, Chariteplatz 1, Mitte, Berlin
Klinikum Bayreuth GmbH
Klinik fuer Neurologie, Hohe Warte 8, Gruener Baum, Bayreuth
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Studienzentrum, Muensterplatz 32, Mitte, Ulm
Universitaetsklinikum Muenster AöR
Klinik f. Neurologie mit Institut f.Transl. Neurol, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Ulm AöR
Klinik fuer Neurologie, Oberer Eselsberg 45, Eselsberg, Ulm
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik fuer Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Tuebingen AöR
Abteilung fuer Neurodegenerative Erkrankungen, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts
Klinik fuer Neurologie, Heinz-Galinski-Strasse 1, Wedding, Berlin
Pharmakologisches Studienzentrum Chemnitz GmbH
N/A, Carolastrasse 2, Zentrum, Chemnitz
Neurologie in Bonn
Neurologie, Neurologie in Bonn, Koelnstr. 54, Bonn
S-Medicon Egészségügyi Szolgáltató Kft.
Neurológia, Megyeri ut 53., 1045, Budapest
University Of Pecs
Neurológiai Klinika, Ret Utca 2, 7623, Pecs
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
Neurológiai Osztály, Koves Ut 1, 1204, Budapest
Ospedale San Raffaele S.r.l.
Neurology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Neurology, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Neurology, Viale Oxford 81, 00133, Rome
IRCCS Ospedale Policlinico San Martino
Neurology, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Socio Sanitaria Territoriale Della Valle Olona
Neurology, Via Arnaldo Da Brescia 1, 21052, Busto Arsizio
Azienda Sanitaria Locale Della Provincia Di Biella
Neurology, Via Dei Ponderanesi 2, 13875, Ponderano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Via Giuseppe Ciotti N. 154, 25018, Montichiari
Azienda Ospedaliero Universitaria Delle Marche
Neurology, Via Conca 71, 60126, Ancona
Fondazione Istituto G. Giglio Di Cafalu
Neurology, Contrada Pietra Pollastra Snc, 90015, Cefalu'
IRCCS Foundation Istituto Neurologico Carlo Besta
Neurology, Via Giovanni Celoria 11, 20133, Milan
Azienda Ospedaliero-Universitaria Sant Andre
Neurology, Via Di Grottarossa 1035-1039, 00189, Rome
Latvijas Juras medicinas centrs AS
Neurology, Vecmilgravja 5. Linija 26, LV-1015, Riga
Pauls Stradins Clinical University Hospital
Neurology, Pilsonu Iela 13, 1002, Riga
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department of Neurology, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department of Neurology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Zuyderland Medisch Centrum Stichting
Department of Neurology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Neuroprotect Sp. z o.o.
N/A, Ul. Klaudyny 16c, 01-684, Warsaw
Neuro-Medic Sp. z o.o.
N/A, Ul. Zurawia 80, 40-686, Katowice
Ma-Lek Clinical Sp. z o.o.
N/A, Ul. Zaleska 9, 40-571, Katowice
Wojewodzki Szpital Specjalistyczny W Olsztynie
Oddział Neurologiczny, Ul. Zolnierska 18, 10-561, Olsztyn
Vitamed Galaj I Cichomski Sp. j.
N/A, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Neuro-Care Sp. z o.o. sp.k.
N/A, Ul. Pawla Kolodzieja 8, 40-749, Katowice
Krakowska Akademia Neurologii Sp. z o.o.
N/A, Ul. Arianska 7/3, 31-505, Cracow
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
N/A, ul. Fabianowska 40, 62-064, Plewiska
Copernicus Podmiot Leczniczy Sp. z o.o.
Oddział Neurologiczny, Nowe Ogrody 1-6, 80-803, Gdańsk
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
N/A, Fitelberga 34/1, 40-588, Katowice
Centrum Neurologii Krzysztof Selmaj
N/A, Ul.Tylna 12, 90-324, Łódź
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddział Neurologii Oddział Udarowy i Wczesnej Rehabilitacji Poudarowej, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
CCAB Centro Clinico Academico Braga Associacao
Neurologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santa Maria E.P.E.
Neurologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Coimbra E.P.E.
Neurologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Almada-Seixal E.P.E.
Neurologia, Avenida Torrado Da Silva, 2805-267, Almada
Clubul Sanatatii S.R.L.
Compartiment Cercetare, Secţia de Neurologie, Bulevardul Bratianu I. C. 54b, 115100, Campulung
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
Neurologicka ambulancia, Nova 21, Foncorda, Banska Bystrica
Fakultna Nemocnica S Poliklinikou Zilina
Neurologicke oddelenie, Vojtecha Spanyola 43, 010 01, Zilina
University Hospital Bratislava
Neurologicka klinika SZU a UNB, Ruzinovska 6, Ruzinov, Bratislava
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Puerta De Hierro De Majadahonda
Neurology, Calle De San Martin De Porres 4, 28035, Madrid
Hospital Clinico San Carlos
Neurology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Complexo Hospitalario Universitario De Santiago
Neurology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario De La Princesa
Neurology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitari Vall D Hebron
Neurology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Santa Caterina Ias
Neurology, Calle Del Doctor Castany S/N, 17190, Salt
Hospital Universitario Basurto
Neurology, Montevideo Etorbidea 16-18, 48013, Bilbao
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of Neurology, Bla Straket 5, 413 46, Goteborg
Region Stockholm – SLSO
Department of Neurology, Solnavagen 1 E, S:t Matteus, Stockholm
Karolinska University Hospital
Department of Clinical Neuroscience, Kirurgigaten 53, 141 86, Stockholm
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-11-18 | 2022-11-22 | 2023-02-15 | ||
| Belgium | 2022-11-09 | 2022-11-17 | 2022-12-29 | ||
| Bulgaria | 2022-09-07 | 2022-09-26 | 2023-01-05 | ||
| Croatia | 2022-09-26 | 2022-11-14 | 2023-03-01 | ||
| Czechia | 2022-09-13 | 2022-09-14 | 2023-03-14 | ||
| Estonia | 2022-08-31 | 2022-09-15 | 2022-10-12 | ||
| Finland | 2022-10-31 | 2023-01-05 | 2023-01-05 | ||
| France | 2022-08-19 | 2022-08-23 | 2022-12-07 | ||
| Germany | 2022-10-25 | 2022-11-14 | 2023-08-30 | ||
| Hungary | 2022-12-14 | 2022-12-20 | 2023-04-06 | ||
| Italy | 2022-07-21 | 2022-08-04 | 2023-05-02 | ||
| Latvia | 2022-07-22 | 2022-08-08 | 2022-10-19 | ||
| Lithuania | 2022-06-27 | 2022-08-23 | 2022-12-04 | ||
| Netherlands | 2022-11-29 | 2022-12-16 | 2022-12-23 | ||
| Poland | 2022-10-19 | 2022-10-27 | 2023-03-15 | ||
| Portugal | 2022-11-29 | 2022-12-22 | 2023-06-05 | ||
| Romania | 2022-11-23 | 2023-02-10 | 2023-02-10 | ||
| Slovakia | 2022-08-18 | 2022-08-22 | 2023-01-11 | ||
| Spain | 2022-06-23 | 2022-07-18 | 2023-03-23 | ||
| Sweden | 2022-11-15 | 2022-11-16 | 2022-12-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-89994
- Event date
- 2025-07-02
- Date aware
- 2025-06-05
- Submission date
- 2025-07-15
- Member states affected
- Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Portugal, Romania, Spain, Sweden, Netherlands, Poland, Slovakia
- Clinical procedures
- Additional sampling for liver functional tests (LFT) are needed at baseline for all study participants and for monitoring symptomatic participants.
- Event description
- Clinically significant liver injury, without findings of viral
hepatitis, requiring screening, monitoring and discontinuation
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 140 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505974-14-00 Redacted.pdf | 2 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement_Blank page | N/A |
| Recruitment arrangements (for publication) | K_Recruitment arrangement_Blank page | NA |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K0_Cover Letter_BG | N/A |
| Recruitment arrangements (for publication) | K0_Cover Letter_SM-6_BG | N/A |
| Recruitment arrangements (for publication) | K1_2023-505974-14_Recruitement Arrangements_Blank page_FRA_San | NA |
| Recruitment arrangements (for publication) | K1_Recritment arrangement_blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Blank page | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ placeholder_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank Page | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank Page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Blank page | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank page_san | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_san | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Blank page | N/A |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and ICF_Master Main ICF_san | 2 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF_Main ICF_EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF_Main ICF_BG_san | V02BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF_Master IAF ICF_san | 2 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF_Main IAF ICF_EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF_Main IAF ICF_BG_san | V02BGR1.0 |
| Subject information and informed consent form (for publication) | L1_IAF ICF_TC | V2.0HRV2.0 |
| Subject information and informed consent form (for publication) | L1_IAF ICF_V2.0HRV1.0 | V2.0HRV2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_hu | 2.0 |
| Subject information and informed consent form (for publication) | L1_List of planned Clinical Trial Sites_red | V4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF V2.0HRV3.0 | V2.0HRV4.0 |
| Subject information and informed consent form (for publication) | L1_Optional RBR ICF_V1.0HRV1.0 | 1.0HRV1.0 |
| Subject information and informed consent form (for publication) | L1_Patient card_v1_22Nov2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FSR_Clean_nonred_san | V2.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF Clean_nonred_san | V2.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_san | V2.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form_lv_san | V02LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form_ru_san | V02LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_nonred_san | V3.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_lv_red_san | V02LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ru_red_san | V02LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_san | V2.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional RBR_san | V1.0LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Baby Health Information | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CSSR | V1ESPes1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_Main ICF_red_san | V2.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_Pregnancy ICF_san | V2.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_RBR FSR_san | V1.0DEU3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dry Run MRI Scan_clean_red-san | V1.0ITA02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dry Run MRI_san | V1.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_san | 10.1PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF ICF_EN | V2.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF ICF_Redacted_san | V2.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF ICF_RO | V2.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_clean | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_san | 2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_san | V2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_swe_tc | V2.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_TC_fi | V2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Health ICF_san | V2.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | V2ESPes1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | V2.0AUT4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_san | V2.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Appendix_san | V2.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main IAF | 2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_already enrolled patient_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_clean_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_et_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_red-san | V2.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted_san | 2.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ru_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_San | 2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_San | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_San | 2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_red-san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted_san | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional RBR_red-san | V1.0PRT3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_san | V1.0DEU3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_san | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS Main_hu_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1-1_2023-505974-14_ICF_Study_FRA_San | V2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1-2_2023-505974-14_ICF_Infant Health Information_FRA_San | V2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L2_2023-505974-14_Other Patient Material_Patient Card_FRA_San | V1.0 |
| Subject information and informed consent form (for publication) | L2_ICF RBR_hu | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_san | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_san | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Data processing description_san | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IAF GDPR ICF_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IAF ICF_clean_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IAF ICF_enrolled subject_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IAF ICF_site specific 353834_clean_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IAF ICF_site specific 353834_enrolled subject_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Infant Health Questionnaire _final_swe_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Infant Health Questionnaire_fi | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Main GDPR ICF_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Main ICF_site specific 353834_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Optional RBR ICF_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_san | V1 |
| Subject information and informed consent form (for publication) | L2_Patient card_HUN_san | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_IAF_EN_San | 2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_IAF_et_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_IAF_FR_San | 2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_IAF_NL_San | 2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_IAF_ru_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_SIS RBR_hu | 1.0 |
| Subject information and informed consent form (for publication) | L3_IAF ICF_Clean_san | 2 |
| Subject information and informed consent form (for publication) | L3_ICF IAF_hu | 1.0 |
| Subject information and informed consent form (for publication) | L3_List of submitted documents_hu_en | NA |
| Subject information and informed consent form (for publication) | L3_SIS IAF_hu | 1.0 |
| Subject information and informed consent form (for publication) | L4_List of submitted documents_en | 1 |
| Subject information and informed consent form (for publication) | L4_List of submitted documents_en_hu_san | SM-7 |
| Subject information and informed consent form (for publication) | L4_List of submitted documents_hu | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-ocrelizumab | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-505974-14-00.pdf | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_at-de-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-de-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-fr-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-nl-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_bg-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_cz-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_lt-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl-nl-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pt-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ro-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_SE-SE-2023-505974-14-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_sk-2023-505974-14-00 | 1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | Estonia | Acceptable 2024-07-08
|
2024-07-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-28 | Acceptable 2024-07-08
|
2024-10-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-22 | Estonia | Acceptable | 2025-01-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-22 | Acceptable | 2025-02-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-22 | Acceptable | 2025-02-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-27 | Acceptable | 2025-01-23 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-17 | Estonia | Acceptable 2025-07-28
|
2025-07-28 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-25 | Estonia | Acceptable 2025-07-28
|
2025-09-25 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-23 | Acceptable | 2026-01-19 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-28 | Estonia | Acceptable 2026-03-30
|
2026-03-30 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-21 | Acceptable 2026-03-30
|
2026-05-21 |