drugset / Trial / NCT04688788
Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis
Phase 3
Active not recruiting
600 enrolled
Rigshospitalet, Denmark
Aalborg University Hospital · collabAarhus University Hospital · collabDanske Regioner · collabGCP-unit at Aarhus University Hospital, Aarhus, Denmark · collabGødstrup Hospital · collabHerlev Hospital · collabHillerod Hospital, Denmark · collabHospital of Central Denmark Region, Viborg, Denmark · collabHospital of South West Jutland, Esbjerg, Denmark · collabHospital of Southern Jutland, Aabenraa, Denmark · collabHospital of Southern Jutland, Sønderborg, Denmark · collabHvidovre University Hospital · collabKolding Sygehus · collabOdense University Hospital · collabSanquin Research & Blood Bank Divisions · collabUniversity of Copenhagen · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The DanNORMS study is a phase 3, non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.
Timeline
- Start
- 2021-04-28
- Primary completion
- 2026-06-10
- Completion
- 2029-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ocrelizumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Acetaminophen | Small molecule | 1000 mg | Oral |
| Background | Fexofenadine | Unknown | 360 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 100 mg | Oral |