Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Primary Progressive Multiple Sclerosis
- Relapsing Remitting Multiple Sclerosis
- Secondary Progressive Multiple Sclerosis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective, 2:1 randomized, open-label, multi-centre, phase 3 non-inferiority clinical trial with blinded primary endpoint.Masking: Single (Outcomes Assessor)Masking Description: MRI scan data will be transfered to the MRI Reader Centre with pseudonymized identity and without any information regarding the treatment allocation of the patient.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The DanNORMS study will include patients with active multiple sclerosis aged 18-65 years. Patients will be randomized in a 2:1 ratio to either rituximab or ocrelizumab. The study duration is 24 months, and patients can continue in an extension phase for additional 36 month. The primary endpoint is t...
The DanNORMS study will include patients with active multiple sclerosis aged 18-65 years. Patients will be randomized in a 2:1 ratio to either rituximab or ocrelizumab. The study duration is 24 months, and patients can continue in an extension phase for additional 36 month. The primary endpoint is the percentage of patients without new or enlarging T2 white matter lesions on brain MRI scans from month 6 to month 24, which will be assessed by radiologists blinded to the treatments status. The study will evaluate a number of efficacy and safety endpoints using clinical, MRI, routine blood samples and research biomarkers.
Tracking Information
- NCT #
- NCT04688788
- Collaborators
- Aalborg University Hospital
- Odense University Hospital
- Aarhus University Hospital
- Herlev Hospital
- Danske Regioner
- Hillerod Hospital, Denmark
- Zealand University Hospital
- Kolding Sygehus
- Regional Hospital Holstebro
- Hospital of Central Denmark Region, Viborg, Denmark
- Hvidovre University Hospital
- Hospital of South West Jutland, Esbjerg, Denmark
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark
- Hospital of Southern Jutland, Sønderborg, Denmark
- GCP unit, Copenhagen University Hospital
- Investigators
- Principal Investigator: Jeppe Romme Christensen, MD, PhD Danish Multiple Sclerosis Center Rigshospitalet
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