RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS

Sponsor
Karolinska Institutet
Study ID
NCT03979456
Phase
PHASE3
Status
Unknown

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex
ALL
Age
20 Years - 52 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    After one year in the trial, the patients are split in the two dosing-arms described above. The dose-comparison phase continues four years.

Study Details

A randomized trial of long-term dosage of rituximab in multiple sclerosis

Key Dates

Start date
Jul 4, 2018
Status verified
Apr 2021
Primary completion
Dec 20, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 6-month dosing interval
    This arm is receiving standard dose rituximab 500 mg every 6 months
  • Experimental: 12-month dosing interval
    This arm is receiving the comparator dose rituximab 500 mg every 12 months

Primary Outcome Measure

No evidence of disease activity (NEDA) [ Time Frame: 3 years ]

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