Overview
Sponsor-declared trial summary
Multiple Sclerosis
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 Mar 2022 → ongoing
- Decision date (initial)
- 2024-09-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513193-22-00
- EudraCT number
- 2021-004791-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response, Pharmacodynamic
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.
Conditions and MedDRA coding
Multiple Sclerosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria
- Age of 18 or older
- EDSS score of 0 to 6.5 inclusive
- Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion)
- Last ocrelizumab interval not extended, maximum of 7,5 months between the infusions
Exclusion criteria 5
- Previous treatment with alemtuzumab, cladribine or stem cell transplantation
- Relapse in the past 3 months prior to inclusion
- Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion
- Inability to undergo regular MRI scanning
- Women who are pregnant or expect to become pregnant during the study period
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
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
- INTRAVENOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 48000 mg milligram(s)
- Max treatment duration
- 480 Month(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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- J.Killestein
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- J.Killestein
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 296 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-03-16 | 2022-04-20 | 2025-02-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513193-22-00 | 7 |
| Recruitment arrangements (for publication) | Recruitment statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF BLOOMS Dutch 2024-513193-22-00 | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Extensie fase 2024-513193-22-00 dd 09-04-2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SPC Ocrelizumab | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Netherlands | Acceptable with conditions 2024-09-17
|
2024-09-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-17 | Netherlands | Acceptable with conditions | 2026-02-03 |