NCT03979456

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

RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple Sclerosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 20 Years – 52 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective randomized phase 3 study comparing two dosing regimens of Rituximab in long-term treatment of MS. Primary endpoint is no evidence of disease activity (NEDA) in a non-inferiority analysis between 12-months dosing interval of 500 mg rituximab with 6-months dosing interval. The endpoint is a compound of being free from release, new or enlarging MRI lesions and sustained progression of disability measured by EDSS. Each patient will have one treating physician responsible for all ongoing medical questions and decisions regarding continuation in the study and one examining physician performing the blinded Expanded Disability Status Scale examination and assessments of exacerbations. The coordinating nurse will administer the study-related tests and administer the rituximab infusions. MRI investigations will be performed blinded for the dosing arm allocation. Randomization will be performed via a randomization module in the national Swedish MS registry. The patients will be randomized in a 1:1 ratio and receive their treatments in accordance with clinical practice. Thus, the study will mimic the real-life situation in which the treatments will be administered. This will lead to a high degree of validity in relation to expected outcome in clinical practice.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

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

Timeline

• Start date: 2018-07-04
• Primary completion: 2024-12-20
• Completion: 2025-06-01
• First posted: 2019-06-07
• Last updated: 2021-04-19

Locations

17 sites across 1 country: Sweden