Clinical trial • Phase IV • Neurology

NATALIZUMAB for Relapsing-remitting multiple sclerosis | Multiple sclerosis

Phase IV trial of NATALIZUMAB for Relapsing-remitting multiple sclerosis | Multiple sclerosis. 440 participants.

Overview

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

Key dates

Initial CTIS Submission Date
22-07-2024
First CTIS Authorization Date
30-07-2024

Trial design

Phase IV trial across 17 sites in Netherlands.

Target Sample Size
440
Trial Duration For Participant
730

Eligibility

Recruits 440 No vulnerable population selected; participants must provide written informed consent. No assent procedures or specific vulnerable population consent processes are described..

Vulnerable Population
No vulnerable population selected; participants must provide written informed consent. No assent procedures or specific vulnerable population consent processes are described.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria\n- 6 or more consecutive natalizumab infusions\n- 18 years or older\n- Agreed to participate (written informed consent)"}

Exclusion criteria

  • {"criterion_text":"- High titer natalizumab (>100AU/ml) antibodies\n- 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 endpoints

  • {"endpoint_text":"- Radiological disease activity (new/enlarging T2 lesions on brain MRI) after two years","definition_or_measurement_approach":"Radiological disease activity measured as new or enlarging T2 lesions on brain MRI assessed after two years"}

Recruitment

Planned Sample Size
440
Recruitment Window Months
66
Consent Approach
Written informed consent required from participants. Eligibility includes 'Agreed to participate (written informed consent)'. Trial documents include 'L1_ SIS and ICF SUPERNEXT Dutch' (in Dutch). Participants are adults (18+); no assent process described.

Geography

Total Number Of Sites
17
Total Number Of Participants
440

Netherlands

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
549
Number Of Sites
17
Number Of Participants
440

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Neurology
Contact Person Name
Beatrijs Wokke
Contact Person Email
b.wokke@erasmusmc.nl
Site Name
Alrijne Zorggroep Stichting
Department Name
Neurology
Contact Person Name
Elske Hoitsma
Contact Person Email
ehoitsma@alrijne.nl
Site Name
Flevoziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Anke Vennegoor
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Luuk van Rooij
Contact Person Email
RooijL@maasstadziekenhuis.nl
Site Name
Amphia Hospital
Department Name
Neruology
Contact Person Name
Casper van Munster
Contact Person Email
CvanMunster@amphia.nl
Site Name
Ommelander Ziekenhuis Groningen B.V.
Department Name
Neurology
Contact Person Name
Jessica Nielsen
Contact Person Email
j.nielsen@ozg.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Neurology
Contact Person Name
Marijke Eurelings
Contact Person Email
meurelings@spaarnegasthuis.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Jeroen van Eijk
Contact Person Email
research-neurologie@jbz.nl
Site Name
Elisabeth-TweeSteden Ziekenhuis
Department Name
Neurology
Contact Person Name
Edo Arnoldus
Contact Person Email
e.arnoldus@etz.nl
Site Name
Diakonessenhuis Stichting
Department Name
Neurology
Contact Person Name
Willem Bouvy
Contact Person Email
wetenschapsbureau@diakhuis.nl
Site Name
Isala Klinieken Stichting
Department Name
Neurology
Contact Person Name
Onno Groeneveld
Contact Person Email
o.n.groeneveld@isala.nl
Site Name
Reinier de Graaf Groep
Department Name
Neurology
Contact Person Name
Jolijn Kragt
Contact Person Email
j.kragt@rdgg.nl
Site Name
Slingeland Ziekenhuis
Department Name
Neurology
Contact Person Name
Christiaan Roosendaal
Contact Person Email
c.roosendaal@slingeland.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Neurology
Contact Person Name
Erwin Hoogervorst
Site Name
OLVG
Department Name
Neurology
Contact Person Name
Nienke Kalkers
Contact Person Email
N.F.Kalkers@olvg.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
Jop Mostert
Contact Person Email
JMostert@rijnstate.nl
Site Name
VUmc Stichting
Department Name
Neurologie
Contact Person Name
Joep Killestein
Contact Person Email
next-ms@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Tysabri 300 mg concentrate for solution for infusion
Active Substance
NATALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
300 mg
Maximum Dose
300 mg
Investigational Product Name
Tyruko 300 mg concentrate for solution for infusion
Active Substance
NATALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
300 mg
Maximum Dose
300 mg
Investigational Product Name
Tysabri 150 mg solution for injection in pre-filled syringe
Active Substance
NATALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Authorised
Starting Dose
150 mg
Maximum Dose
300 mg

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