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

Sponsor
Oslo University Hospital
Study ID
NCT04121403
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Biosimilar rituximab concentrate for solution for infusion
  • Cladribine — DRUG
    Mavenclad oral cladribine tablets

Study Details

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.

Key Dates

Start date
Oct 16, 2019
Status verified
Dec 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    Biosimilar rituximab concentrate for solution for infusion
  • Active Comparator: Cladribine
    Mavenclad oral cladribine tablets

Primary Outcome Measure

Number of new or enlarging cerebral MRI T2 lesions [ Time Frame: Week 12-96 ]

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