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Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)

NCT ID: NCT04121403

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2024-08-31

Brief Summary

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The main aim and overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of relapsing MS. Secondly, the investigators will test specific blood and MRI biomarkers that may contribute to future personalized treatment for MS patients. Furthermore, the investigators want to evaluate the health economic consequences of the two therapies.

Detailed Description

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Multiple sclerosis (MS) is a demyelinating and neurodegenerative inflammatory disease of the central nervous system, affecting more than 12 000 patients in Norway and more than 2.2 mill patients worldwide.

Oral cladribine is one of the first choices for highly efficient disease modulatory treatment (DMT), while Rituximab is used off-label as DMT in relapsing MS. Large observational studies indicate good tolerance and treatment effect of rituximab in MS and studies from other diseases indicate a good safety profile. However, no phase 3 studies have been performed to test whether rituximab is as efficient as established MS treatments. Formal safety data is also lacking for the treatment with rituximab in MS.

The investigators will perform a prospective randomized open-label blinded endpoint multicenter non-inferiority study. The primary objective is to test whether rituximab is non-inferior to oral cladribine in the treatment of relapsing MS. 264 MS patients aged 18-65 years with relapsing MS will be recruited from 10 centers and followed for 96 weeks. The primary endpoint is difference in new T2 lesions between the groups. Furthermore, the investigators will test novel blood sample and MRI biomarkers to provide tools for personalized MS treatments. Finally, the health economic consequences of these treatment options will be evaluated.

This study will guide clinicians and patients in the future treatment choice for MS and can potentially make a huge impact on the costs of future MS treatment.

Conditions

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Relapsing Multiple Sclerosis Multiple Sclerosis

Keywords

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multiple sclerosis ms rms rituximab cladribine probe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study, designed to establish non-inferiority of the test treatment rituximab compared with the comparator oral cladribine for consecutively included patients with active RMS. Randomization rituximab:cladribine is 1:1.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Two independent blinded radiologists assess the primary endpoint, New or enlarging T2 lesions. The blinding is asserted by transfer of deidentified MRIs to a Research server, from where the assessment is performed, so that the radiologists know only the ID, not the treatment allocation of the patients from whom the assess MRIs.

Study Groups

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Rituximab

Biosimilar rituximab concentrate for solution for infusion

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type BIOLOGICAL

Biosimilar rituximab concentrate for solution for infusion

Cladribine

Mavenclad oral cladribine tablets

Group Type ACTIVE_COMPARATOR

Cladribine

Intervention Type DRUG

Mavenclad oral cladribine tablets

Interventions

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Rituximab

Biosimilar rituximab concentrate for solution for infusion

Intervention Type BIOLOGICAL

Cladribine

Mavenclad oral cladribine tablets

Intervention Type DRUG

Other Intervention Names

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Mavenclad

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 65 years
* A diagnosis of relapsing MS according to the 2017 McDonald criteria
* Disease activity seen as either a clinical relapse or MRI activity during the last 12 months
* EDSS between 0 and 5.5
* Thrombocytes and leukocytes within normal range, and lymphocytes above 0.8 x10 9/L before first dose of study medication
* A) For women of childbearing potential: accepting to use adequate contraception in the trial period. If randomized to cladribine, women who use systemic hormonal contraception must accept to use additional barrier contraception during each treatment cycle and for four weeks after each treatment cycle.
* B) For men: If randomized to cladribine, accepting to use adequate contraception in the safety period of 6 months after each treatment cycle.
* Able to understand written and spoken Norwegian or English
* Able to complete treatment or follow-ups in the study (e.g. no contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving)
* Signed informed consent

Exclusion Criteria

* Any contraindication or increased risk of side-effects from rituximab or cladribine (such as ongoing acute or chronic infection, live vaccination less than 4 weeks before start of treatment or planned live vaccination, immunocompromised, previous or active malignant disease, ongoing glucocorticoid treatment or allergy against any products of the medication)
* Previous use of any of cladribine, rituximab, alemtuzumab, ocrelizumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression with long lasting effects
* Fingolimod or natalizumab treatment within the last six months before inclusion
* Current pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Sykehuset Ostfold

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gro Owren Nygaard

Gro Owren Nygaard, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanne Flistad Harbo, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Gro Owren Nygaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Department of Neurology - Drammen, Vestre Viken HF

Drammen, Buskerud, Norway

Site Status

Department of Neurology - Lillehammer, SI Lillehammer

Lillehammer, Oppland, Norway

Site Status

Department of Neurology, Stavanger universitetssykehus

Stavanger, Rogaland, Norway

Site Status

Department of Neurology - Førde, Helse Førde HF

Førde, Sogn Og Fjordane, Norway

Site Status

Department of Neurology - Skien, Sykehuset Telemark

Skien, Telemark, Norway

Site Status

Department of Neurology - Tromsø, University Hospital of North Norway

Tromsø, Troms, Norway

Site Status

Department of Neurology - Kristiansand, Sørlandet sykehus HF

Kristiansand, Vest-Agder, Norway

Site Status

Department of Neurology - Tønsberg, Sykehuset i Vestfold HF

Tønsberg, Vestfold, Norway

Site Status

Department of Neurology, Oslo University Hospital

Oslo, , Norway

Site Status

St. Olavs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

Department of Neurology - Kalnes, Sykehuset Østfold HF

Sarpsborg, Østfold fylke, Norway

Site Status

Countries

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Norway

Other Identifiers

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11383

Identifier Type: -

Identifier Source: org_study_id