Clinical trial • Phase IV • Neurology
Ocrelizumab for Multiple Sclerosis
Phase IV trial of Ocrelizumab for Multiple Sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Multiple Sclerosis
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 02-09-2024
- First CTIS Authorization Date
- 17-09-2024
Trial design
Randomised, standard ocrelizumab (standard fixed 24 week interval) versus personalized b cell tailored ocrelizumab; investigational product: ocrevus 300 mg concentrate for solution for infusion (active substance ocrelizumab). exact dose and schedule beyond 'fixed 24 week interval' for the comparator arm are not specified in the record.-controlled Phase IV trial across 22 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Standard ocrelizumab (standard fixed 24 week interval) versus personalized B cell tailored ocrelizumab; investigational product: Ocrevus 300 mg concentrate for solution for infusion (active substance ocrelizumab). Exact dose and schedule beyond 'fixed 24 week interval' for the comparator arm are not specified in the record.
- Biomarker Stratified
- True, biomarker: B cell count (B-cell tailored dosing); strata not specified in record
- Target Sample Size
- 296
- Trial Duration For Participant
- 672
Eligibility
Recruits 296 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the documents (L1_SIS and ICF BLOOMS Dutch). No further details about assent or specific consent-handling procedures are provided in the record..
- Pregnancy Exclusion
- Women who are pregnant or expect to become pregnant during the study period
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the documents (L1_SIS and ICF BLOOMS Dutch). No further details about assent or specific consent-handling procedures are provided in the record.
Inclusion criteria
- {"criterion_text":"- A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria\n- Age of 18 or older\n- EDSS score of 0 to 6.5 inclusive\n- Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion)\n- Last ocrelizumab interval not extended, maximum of 7,5 months between the infusions"}
Exclusion criteria
- {"criterion_text":"- Previous treatment with alemtuzumab, cladribine or stem cell transplantation\n- Relapse in the past 3 months prior to inclusion\n- Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion\n- Inability to undergo regular MRI scanning\n- Women who are pregnant or expect to become pregnant during the study period"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Comparison of the difference in percentage of confirmed relapse-free patients between treatment groups after 96 weeks follow-up; and comparison of the difference in percentage of patients without new/enlarging T2 MRI lesions between treatment groups after 96 weeks follow-up."}
Recruitment
- Planned Sample Size
- 296
- Recruitment Window Months
- 62
- Consent Approach
- Informed consent is required; subject information and informed consent forms are listed (L1_SIS and ICF BLOOMS Dutch). The available documents are in Dutch. No additional details on assent, who provides consent for specific vulnerable groups, or multiple language versions are provided in the record.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 296
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-09-2024
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 508
- Number Of Sites
- 22
- Number Of Participants
- 296
Sites
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Jeroen van Eijk
- Principal Investigator Email
- J.Eijkvan@jbz.nl
- Contact Person Name
- Jeroen van Eijk
- Contact Person Email
- J.Eijkvan@jbz.nl
- Site Name
- Haga Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Jurgen Piet
- Principal Investigator Email
- j.piet@hagaziekenhuis.nl
- Contact Person Name
- Jurgen Piet
- Contact Person Email
- j.piet@hagaziekenhuis.nl
- Site Name
- Slingeland Ziekenhuis
- Department Name
- Neurology
- Principal Investigator Name
- Christiaan Roosendaal
- Principal Investigator Email
- C.Roosendaal@slingeland.nl
- Contact Person Name
- Christiaan Roosendaal
- Contact Person Email
- C.Roosendaal@slingeland.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Neurology
- Principal Investigator Name
- Ruben Portier
- Principal Investigator Email
- R.Portier@mst.nl
- Contact Person Name
- Ruben Portier
- Contact Person Email
- R.Portier@mst.nl
- Site Name
- Ommelander Ziekenhuis Groningen B.V.
- Department Name
- Neurology
- Principal Investigator Name
- Jessica Nielsen
- Principal Investigator Email
- j.nielsen@ozg.nl
- Contact Person Name
- Jessica Nielsen
- Contact Person Email
- j.nielsen@ozg.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Neurology
- Principal Investigator Name
- Erwin Hoogervorst
- Principal Investigator Email
- e.hoogervorst@antoniusziekenhuis.nl
- Contact Person Name
- Erwin Hoogervorst
- Contact Person Email
- e.hoogervorst@antoniusziekenhuis.nl
- Site Name
- Flevoziekenhuis Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Anke Vennegoor
- Principal Investigator Email
- wetenschapsbureau@flevoziekenhuis.nl
- Contact Person Name
- Anke Vennegoor
- Contact Person Email
- wetenschapsbureau@flevoziekenhuis.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Bjorn van Geel
- Principal Investigator Email
- B.M.van.Geel@nwz.nl
- Contact Person Name
- Bjorn van Geel
- Contact Person Email
- B.M.van.Geel@nwz.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Neurology
- Principal Investigator Name
- Ide Smets
- Principal Investigator Email
- i.smets@erasmusmc.nl
- Contact Person Name
- Ide Smets
- Contact Person Email
- i.smets@erasmusmc.nl
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Neurology
- Principal Investigator Name
- Koen de Gans
- Principal Investigator Email
- Koen.de.Gans@ghz.nl
- Contact Person Name
- Koen de Gans
- Contact Person Email
- Koen.de.Gans@ghz.nl
- Site Name
- Wilhelmina Ziekenhuis Assen
- Department Name
- Neurology
- Principal Investigator Name
- Mark Kloosterziel
- Principal Investigator Email
- Mark.Kloosterziel@WZA.NL
- Contact Person Name
- Mark Kloosterziel
- Contact Person Email
- Mark.Kloosterziel@WZA.NL
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Luuk van Rooij
- Principal Investigator Email
- RooijL@maasstadziekenhuis.nl
- Contact Person Name
- Luuk van Rooij
- Contact Person Email
- RooijL@maasstadziekenhuis.nl
- Site Name
- Streekziekenhuis Koningin Beatrix
- Department Name
- Neurology
- Principal Investigator Name
- Ilse Arts
- Principal Investigator Email
- i.arts@skbwinterswijk.nl
- Contact Person Name
- Ilse Arts
- Contact Person Email
- i.arts@skbwinterswijk.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Onno Groeneveld
- Principal Investigator Email
- o.n.groeneveld@isala.nl
- Contact Person Name
- Onno Groeneveld
- Contact Person Email
- o.n.groeneveld@isala.nl
- Site Name
- OLVG
- Department Name
- Neurology
- Principal Investigator Name
- Nynke Kalkers
- Principal Investigator Email
- N.F.Kalkers@olvg.nl
- Contact Person Name
- Nynke Kalkers
- Contact Person Email
- N.F.Kalkers@olvg.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Liselore Mensing
- Principal Investigator Email
- lmensing@spaarnegasthuis.nl
- Contact Person Name
- Liselore Mensing
- Contact Person Email
- lmensing@spaarnegasthuis.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Neurology
- Principal Investigator Name
- Jolijn Kragt
- Principal Investigator Email
- wetenschapsbureau@rdgg.nl
- Contact Person Name
- Jolijn Kragt
- Contact Person Email
- wetenschapsbureau@rdgg.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Oliver Gerlach
- Principal Investigator Email
- ol.gerlach@zuyderland.nl
- Contact Person Name
- Oliver Gerlach
- Contact Person Email
- ol.gerlach@zuyderland.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Joep Killestein
- Principal Investigator Email
- j.killestein@amsterdamumc.nl
- Contact Person Name
- Joep Killestein
- Contact Person Email
- j.killestein@amsterdamumc.nl
- Site Name
- Alrijne Zorggroep Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Elske Hoitsma
- Principal Investigator Email
- ehoitsma@alrijne.nl
- Contact Person Name
- Elske Hoitsma
- Contact Person Email
- ehoitsma@alrijne.nl
- Site Name
- Amphia Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Caspar van Munster
- Principal Investigator Email
- CvanMunster@amphia.nl
- Contact Person Name
- Caspar van Munster
- Contact Person Email
- CvanMunster@amphia.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Jop Mostert
- Principal Investigator Email
- JMostert@rijnstate.nl
- Contact Person Name
- Jop Mostert
- Contact Person Email
- JMostert@rijnstate.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
- Ocrevus 300 mg concentrate for solution for infusion
- Active Substance
- Ocrelizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Authorised (marketing authorisation EU/1/17/1231/001)
- Maximum Dose
- 600 mg
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