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

Summary

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.

Conditions

• Relapsing Multiple Sclerosis
• Multiple Sclerosis

Interventions

BIOLOGICAL

Rituximab

Biosimilar rituximab concentrate for solution for infusion

DRUG

Cladribine

Mavenclad oral cladribine tablets

Sponsors & Collaborators

• University of Oslo

  collaborator OTHER

• Sykehuset Ostfold

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Vestre Viken Hospital Trust

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Helse Stavanger HF

  collaborator OTHER_GOV

• Sykehuset Innlandet HF

  collaborator OTHER

• Sykehuset i Vestfold HF

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Hanne Flistad Harbo, MD, PhD · Oslo University Hospital

• Gro Owren Nygaard, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-16

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Norway

Study Locations