Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
516
Countries
6
Sites
49
Multiple Sclerosis
1. PK Group: To demonstrate PK comparability of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus in patients with RRMS 2. Main Study Group: To demonstrate the non-inferiority of CT-P53 to reference drug (EU-approved Ocrevus and US-licensed Ocrevus) in patients with RRMS
Key facts
- Sponsor
- Celltrion Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 Jan 2024 → ongoing
- Decision date (initial)
- 2023-11-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Celltrion Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Bioequivalence, Efficacy, Pharmacokinetic, Safety
1. PK Group: To demonstrate PK comparability of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus in patients with RRMS
2. Main Study Group: To demonstrate the non-inferiority of CT-P53 to reference drug (EU-approved Ocrevus and US-licensed Ocrevus) in patients with RRMS
Secondary objectives 2
- PK Group: To assess additional PK and PD parameters of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus
- Main Study Group: To assess the additional efficacy, PK, PD and safety including immunogenicity of CT-P53 and reference drug (EU-approved Ocrevus and US-licensed Ocrevus)
Conditions and MedDRA coding
Multiple Sclerosis
| 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 | Ocrevus / CT-P53 This is a double-blind, randomized, active-controlled, parallel group study.
|
Randomised Controlled | Double | [{"id":185845,"code":5,"name":"Carer"},{"id":185847,"code":1,"name":"Subject"},{"id":185846,"code":3,"name":"Monitor"},{"id":185844,"code":2,"name":"Investigator"},{"id":185848,"code":4,"name":"Analyst"}] | CT-P53 treatment group: CT-P53 will be administered for a total of 2 cycles; including two doses of 300 mg of Cycle 1 at Week 0 and Week 2, and then a dose of 600 mg of Cycle 2 at Week 24 by IV. Ocrevus treatment group: EU-Ocrevus or US-Ocrevus will be administered for a total of 2 cycles; including two doses of 300 mg of Cycle 1 at Week 0 and Week 2, and then a dose of 600 mg of Cycle 2 at Week 24 by IV. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient is male or female aged between 18 years and 55 years (both inclusive)
- Patient diagnosed as Multiple Sclerosis (MS) in accordance with the revised McDonald criteria (2017).
- Patient has evidence of recent MS activity as defined in the study protocol.
- Patient has neurological stability for ≥30 days.
- Patient with 0 to 6.0 (both inclusive) on the EDSS score.
Exclusion criteria 6
- Patient diagnosed with primary or secondary progressive MS.
- Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
- Patient unable to complete or has a contraindication to an MRI
- Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
- Patient who has currently or history of any of medical conditions described in the study protocol.
- Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- For PK Group: Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2)
- For PK Group: Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)
- For Main Study Group: Total number of new GdE lesions on T1-weighted brain MRI up to Week 48
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10355752 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELLTRION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
Ocrevus 300 mg concentrate for solution for infusion
PRD5771848 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 96 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
- No
SUB121707 · Substance
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
PRD439896 · Product
- Active substance
- Cetirizine Dihydrochloride
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AE07 — CETIRIZINE
- Marketing authorisation
- PA0891/008/003
- MA holder
- UCB PHARMA IRELAND LTD (DUBLIN IE)
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paracetamol 500 mg HEXAL bei Fieber und Schmerzen, 500 mg Tabletten
PRD829398 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 300 mg/kg milligram(s)/kilogram
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 3599.99.98-5011790
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD1577821 · Product
- Active substance
- Methylprednisolone
- Substance synonyms
- 6-METHYLPREDNISOLONE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- PA 0822/136/002
- MA holder
- PFIZER HEALTHCARE IRELAND
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celltrion Inc.
- Sponsor organisation
- Celltrion Inc.
- Address
- 23 Academy Ro, Yeonsu Gu Yeonsu Gu
- City
- Incheon
- Postcode
- 22014
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Planning
Public contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Operation
Locations
6 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 72 | 12 |
| Croatia | Ongoing, recruitment ended | 12 | 7 |
| Czechia | Ongoing, recruitment ended | 12 | 5 |
| Poland | Ongoing, recruitment ended | 179 | 16 |
| Romania | Ongoing, recruitment ended | 51 | 5 |
| Spain | Ongoing, recruitment ended | 7 | 4 |
| Rest of world
Serbia, North Macedonia, Moldova, Republic of, Ukraine
|
— | 183 | — |
Investigational sites
Multiprofessional Hospital For Active Treatment Health 2012 OOD
Pediatrics level III, Ulitsa Maestro Kinev 4, 1618, Sofiya
Multiprofile Hospital For Active Treatment Elin Pelin EOOD
Nervous Diseases level II, Ulitsa Zdravets 15, 2100, Elin Pelin
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Neurology Clinic, Georgi Benkovski Street 100, 4500, Panagyurishte
Multiprofile Hospital For Active Treatment Avis Medika OOD
Nervous Diseases level II, Ulitsa Kosta Hadzhipakev 7, 5801, Pleven
Medical Center Hera EOOD
NA, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Hera EOOD
NA, Ulitsa Tsar Boris Treti 11a, Fl 2, Montana
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Neurology Clinic, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Alexandrovska University Hospital
Neurology Clinic, Georgy Sofiiski Str 1, 1431, Sofia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Nervous Diseases for movement disorders, Ul. Dr. Lyuben Rusev 1, 1113, Sofia
Sveta Marina Pharma EOOD
Nervous Diseases, Primorski, Hristo Smirnenski Str. 1, Varna
Medicinski Center Syrtuin Ltd.
NA, Lyulin District Bl 142 Floor 3, 1335, Sofia
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Nervous diseases level III, Ulitsa Georgi Kochev 8-A, 5803, Pleven
Klinicki bolnicki centar Sestre milosrdnice
Neuroimunology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Clinical Hospital Centre Osijek
Neurology, Ulica Josipa Huttlera 4, 31000, Osijek
Poliklinika Solmed d.o.o.
NA, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Opca Bolnica Varazdin
Neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin
Clinical Hospital Centre Rijeka
Neurology, Kresimirova 42, 51000, Rijeka
Poliklinika BONIFARM
Clinical and clinical research, Ulica Aleksandra Hondla 2/11, Zagreb, Grad Zagreb
Hospital Jihlava
Neurologické oddělení, Vrchlickeho 59, 586 01, Jihlava 1
Fakultni Nemocnice Hradec Kralove
Neurologická klinika, MS centrum, Sokolska 581, 500 03, Novy Hradec Kralove
Neurohk s.r.o.
N/A, Smetanova 830, 565 01, Chocen
Fakultni Nemocnice Ostrava
Neurologická klinika, 17. Listopadu 1790/5, Poruba, Ostrava
doc. MUDr. Radomír Taláb, CSc.
Neurology, Plácelova 1257/103, Czech Republic, Hradec Králové
ProNeuro Centrum Medyczne
N/A, ul. Aleja Zjednoczonej Europy 37, 44-240, Zory
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Centrum Medyczne Hcp Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Euromedis Sp. z o.o.
N/A, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Resmedica Sp. z o.o.
N/A, Ul. Romualda Mielczarskiego 105/3-4, 25-726, Kielce
Neuro-Medic Sp. z o.o.
N/A, Ul. Zurawia 80, 40-686, Katowice
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
N/A, Ulica Szaserow 128, 04-141, Warsaw
Clinhouse Sp. z o.o.
N/A, Ul. Tarnopolska 77, 41-807, Zabrze
Neurologiczny NZOZ
N/A, Ul. Fabianowska 40, 62-064, Plewiska
Centrum Neurologii Krzysztof Selmaj
N/A, ul. Tylna 12, 90-324, Łódź
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Oddzial Neurologiczny, Ul. 3 Maja 13/15, 41-800, Zabrze
Ilkowski I Partnerzy sp.p. Lekarzy
N/A, Ul. Wierzbowa 2/2, 61-853, Poznan
NZOZ „PRO-FEMINA” Piotr Piech i in Spólka Jawna
N/A, ul. Krośnieńska 1, 42-500, Bedzin
Copernicus Podmiot Leczniczy Sp. z o.o.
Oddzial Neurologiczny, Ul. Nowe Ogrody 1/6, 80-803, Gdansk
Novo-Med Zielinski I Wspolnicy Sp. j.
N/A, Ul. Brynowska 44, 40-584, Katowice
Neuroprotect Sp. z o.o.
N/A, Ul. Klaudyny 16c, 01-684, Warsaw
Arensia Clinics S.R.L.
Neurology, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Pelican Impex S.R.L.
Neurology, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Spitalul Clinic Judetean De Urgenta Cluj
Neurology, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Spitalul Clinic De Neuropsihiatrie Craiova
Neurology 1, Strada Calea Bucuresti Nr. 99, 200473, Craiova
Clubul Sanatatii S.R.L.
Neurology, Bulevardul Bratianu I. C. 54b, 115100, Campulung
Hospital Universitari Vall D Hebron
Neurology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Neurology, Paseo De La Castellana 261, 28046, Madrid
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-03-06 | 2024-03-07 | 2025-03-27 | ||
| Croatia | 2024-03-25 | 2024-04-24 | 2025-02-18 | ||
| Czechia | 2025-03-26 | 2025-04-15 | 2025-07-01 | ||
| Poland | 2024-01-16 | 2024-01-25 | 2025-07-01 | ||
| Romania | 2024-01-25 | 2024-02-06 | 2025-05-31 | ||
| Spain | 2024-07-29 | 2024-07-31 | 2025-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 86 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clarification letter_Dietary and fluid restrictions for PK group | 1 |
| Protocol (for publication) | Clarification letter_Ig assessment visit window | 1 |
| Protocol (for publication) | Clarification letter_Viral serology follow-up | 1 |
| Protocol (for publication) | CT-P53 3_1_SF_36v2_CZ_08Mar2012_Public | 2.0 |
| Protocol (for publication) | CT-P53 3_1_SF_36v2_ES_08Mar2012_Public | 2.0 |
| Protocol (for publication) | Protocol 2022-501622-37-00_redacted_Public | 3.0 |
| Protocol (for publication) | Protocol 2022-501622-37-00_redacted_Public_track | 3.0 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_BG | 1 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_BG_2 | 1 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_HR | 1 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_PL | 1 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_PL_2 | 1 |
| Protocol (for publication) | Statement on Go-Live of CRF before receiving approval for the Protocol amendment to V2_2_RO | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_CT-P53 3_1_Recruitment-Arrangements_ES_v2_0_12Mar2024_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CT-P53_3-1_Recruitment-Informed-Consent-Procedure_CZ_11Mar2024_Public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ENG | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Informed_Consent_Procedure_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_Letter-to-Lost-To-Follow-Up-Patient_Site-Specific_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_Medical-certificate-of-participation_Site-Specific_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_PCP-HCP-Notification_Site-Specific_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_Treatment-Assignment-Letter_Site-Specific_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | Statement on clarification of recruiting only Non-PK group_Bulgaria_public | 1 |
| Recruitment arrangements (for publication) | Statement on clarification of recruiting only Non-PK group_Croatia | 1 |
| Recruitment arrangements (for publication) | Statement on clarification of recruiting only Non-PK group_Spain_public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Biomarker_English_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Biomarker_Romanian_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Extension Period_English_Redacted | 2.4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Extension Period_Romanian_Redacted | 2.4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_PK mandatory_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_PK mandatory_Romanian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Romanian_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Newborn_Spanish_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PK substudy_English_Redacted | 2.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PK substudy_Romanian_Redacted | 2.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnancy Partner and Newborn_English | 1.4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnancy Partner and Newborn_Romanian | 1.4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_Spanish_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_Biomarker-ICF_CZ_Czech_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_Biomarker-ICF_PL_Polish_Public | 1.4 |
| Subject information and informed consent form (for publication) | L1_GDPR-ICF_CZ_Czech_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_Main-Extension-Period-ICF_CZ_Czech_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_Main-Extension-Period-ICF_PL_Polish_Public | 2.3 |
| Subject information and informed consent form (for publication) | L1_Main-ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_PK-Substudy-ICF_CZ_Czech_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_PK-Substudy-ICF_PL_Polish_Public | 2.3 |
| Subject information and informed consent form (for publication) | L1_Pregnant-Partner-ICF_CZ_Czech_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_Pregnant-Partner-ICF_PL_Polish_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_Bulgarian_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_Croatian_Public | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_English_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_Spanish_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Extension Period_Croatian_Public | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Extention Period_Bulgarian_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Extention Period_English_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Extention Period_Spanish_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Bulgarian_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Croatian_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Spanish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy and Newborn_Croatian_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner and Newborn_Bulgarian_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner and Newborn_English_Public | 1.2 |
| Subject information and informed consent form (for publication) | L2_Patient card Bulgaria_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient card Croatia_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient card Romania_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient-Card_PL_POL_Public | 1 |
| Subject information and informed consent form (for publication) | L2_SF_36v2_CZ_Czech_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_SF-36 Survey Bulgaria | 1 |
| Subject information and informed consent form (for publication) | L2_SF-36 Survey Croatia | 1 |
| Subject information and informed consent form (for publication) | L2_SF-36 Survey Romania | 1 |
| Subject information and informed consent form (for publication) | L2_SF-36v2-Patient-Questionnaire_PL_POL_Public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Prescribing Information Ocrevus | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ocrevus | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_BG_2022-501622-37-00_redacted_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_CZ_2022-501622-37-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_ENG_2022-501622-37-00_redacted_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_ES_2022-501622-37-00_redacted_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_HR_2022-501622-37-00_redacted_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_PL_2022-501622-37-00_redacted_Public | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_RO_2022-501622-37-00_redacted_Public | 3.0 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | Poland | Acceptable with conditions 2023-08-21
|
2023-10-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-28 | Poland | Acceptable 2024-02-12
|
2024-02-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-27 | Poland | Acceptable 2024-02-12
|
2024-03-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-27 | Poland | Acceptable 2024-02-12
|
2024-03-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-27 | Poland | Acceptable | 2024-04-29 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-04-05 | Acceptable 2024-02-12
|
2024-07-01 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-04-05 | Acceptable 2024-02-12
|
2024-07-01 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-07-04 | Acceptable 2024-02-12
|
2024-07-04 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-07-08 | Acceptable 2024-02-12
|
2024-07-08 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-12 | Poland | Acceptable 2024-10-21
|
2024-10-22 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-10-30 | Poland | Acceptable 2024-10-21
|
2024-10-30 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-08 | Poland | Acceptable 2025-03-03
|
2025-03-04 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-04-23 | Poland | Acceptable 2025-03-03
|
2025-04-23 |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-05-21 | Poland | Acceptable 2025-07-21
|
2025-07-24 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-12-19 | Poland | Acceptable 2026-04-09
|
2026-04-10 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-04-22 | Poland | Acceptable 2026-04-09
|
2026-04-22 |
| 17 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-05-15 | Acceptable | 2026-06-02 |