Overview
Sponsor-declared trial summary
Multiple Sclerosis
Our objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab starting from 6 weeks in a large real-life cohort across the Netherlands.
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
- 30 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513105-31-00
- EudraCT number
- 2019-002566-13
- ClinicalTrials.gov
- NCT04225312
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
Our objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab starting from 6 weeks in a large real-life cohort across the Netherlands.
Conditions and MedDRA coding
Multiple Sclerosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria
- 6 or more consecutive natalizumab infusions
- 18 years or older
- Agreed to participate (written informed consent)
Exclusion criteria 2
- High titer natalizumab (>100AU/ml) antibodies
- Contraindication for yearly magnetic resonance imaging (MRI) (ie, have pacemakers or other contraindicated implanted metal devices, or have claustrophobia that cannot be medically managed)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiological disease activity (new/enlarging T2 lesions on brain MRI) after two years
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Tysabri 300 mg concentrate for solution for infusion
PRD10194542 · Product
- Active substance
- Natalizumab
- Substance synonyms
- AN100226M
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AG03 — -
- Marketing authorisation
- EU/1/06/346/001
- MA holder
- BIOGEN NETHERLANDS B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tyruko 300 mg concentrate for solution for infusion
PRD10854419 · Product
- Active substance
- Natalizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AA23 — -
- Marketing authorisation
- EU/1/23/1745/001
- MA holder
- SANDOZ GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tysabri 150 mg solution for injection in pre-filled syringe
PRD10194555 · Product
- Active substance
- Natalizumab
- Substance synonyms
- AN100226M
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AG03 — -
- Marketing authorisation
- EU/1/06/346/002
- MA holder
- BIOGEN NETHERLANDS B.V.
- MA country
- Iceland
- 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
- L.M.Y. Gelissen
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- L.M.Y. Gelissen
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 440 | 17 |
| 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 | 2024-07-30 | 2024-07-30 | 2024-11-04 |
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 2024-513105-31-00 | 11 |
| Recruitment arrangements (for publication) | Recruitment statement | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF SUPERNEXT Dutch | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Tysabri | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Tyruko | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Netherlands | Acceptable with conditions 2024-07-30
|
2024-07-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-05 | Netherlands | Acceptable with conditions | 2026-01-29 |