Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

April 28, 2021

Primary Completion Date

May 5, 2026

Study Completion Date

May 5, 2029

Conditions
Relapsing Remitting Multiple SclerosisSecondary Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis
Interventions
DRUG

Rituximab

Rituximab is a chimeric mouse/human monoclonal immunoglobulin gamma-1 (IgG1) antibody which depletes cluster of differentiation antigen 20 (CD20)-positive cells. Rituximab is approved for non-hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis and microscopic polyangitis, and pemphigus vulgaris.

DRUG

Ocrelizumab

Ocrelizumab is a recombinant humanised monoclonal IgG1 antibody which depletes CD20-positive cells. Ocrelizumab is approved for multiple sclerosis.

DRUG

Fexofenadine

Premedication with oral fexofenadine 360 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.

DRUG

Paracetamol

Premedication with oral. paracetamol 1000 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.

DRUG

Methylprednisolone

Premedication with oral methylprednisolone 100 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.

Trial Locations (11)

2600

Danish Multiple Sclerosis Center, Rigshospitalet, Glostrup Municipality

2730

Department of Neurology, Herlev Hospital, Herlev

3400

Department of Neurology, Nordsjællands Hospital i Hillerød, Hillerød

5000

Department of Neurology, Odense University Hospital, Odense

6000

Department of Neurology, Kolding Hospital, Kolding

6400

Department of Neurology, Hospital of Southern Jutland, Sønderborg, Sønderborg

6700

Department of Neurology, Hospital of South West Jutland, Esbjerg, Esbjerg

7500

Department of Neurology, Regionshospitalet Holstebro, Holstebro

8200

Department of Neurology, Aarhus University Hospital, Aarhus

8800

Department of neurology, Regionshospitalet Viborg, Viborg

9000

Department of Neurology, Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

Odense University Hospital

OTHER

collaborator

Aarhus University Hospital

OTHER

collaborator

Aalborg University Hospital

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Hillerod Hospital, Denmark

OTHER

collaborator

Kolding Sygehus

OTHER

collaborator

Gødstrup Hospital

OTHER

collaborator

Hvidovre University Hospital

OTHER

collaborator

Hospital of South West Jutland, Esbjerg, Denmark

UNKNOWN

collaborator

GCP unit, Copenhagen University Hospital

UNKNOWN

collaborator

GCP-unit at Aarhus University Hospital, Aarhus, Denmark

OTHER

collaborator

Hospital of Southern Jutland, Sønderborg, Denmark

UNKNOWN

collaborator

Hospital of Central Denmark Region, Viborg, Denmark

UNKNOWN

collaborator

Danske Regioner

OTHER

collaborator

Hospital of Southern Jutland, Aabenraa, Denmark

UNKNOWN

collaborator

Sanquin Research & Blood Bank Divisions

OTHER

lead

Rigshospitalet, Denmark

OTHER