drugset / Trial / NCT04121403
Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)
Phase 3
Completed
267 enrolled
Oslo University Hospital
Helse Stavanger HF · collabSorlandet Hospital HF · collabSt. Olavs Hospital · collabSykehuset Innlandet HF · collabSykehuset Ostfold · collabSykehuset Telemark · collabSykehuset i Vestfold HF · collabUniversity Hospital of North Norway · collabUniversity of Oslo · collabVestre Viken Hospital Trust · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2019-10-16
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cladribine | Small molecule | — | Oral |
| Comparator | Rituximab | Monoclonal antibody | — | — |