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

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.

Conditions

• Relapsing Remitting Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis
• Primary 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.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Kolding Sygehus

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Hospital of South West Jutland, Esbjerg, Denmark

  collaborator UNKNOWN

• GCP unit, Copenhagen University Hospital

  collaborator UNKNOWN

• GCP-unit at Aarhus University Hospital, Aarhus, Denmark

  collaborator OTHER

• Hospital of Southern Jutland, Sønderborg, Denmark

  collaborator UNKNOWN

• Hospital of Central Denmark Region, Viborg, Denmark

  collaborator UNKNOWN

• Danske Regioner

  collaborator OTHER

• Hospital of Southern Jutland, Aabenraa, Denmark

  collaborator UNKNOWN

• Sanquin Research & Blood Bank Divisions

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Jeppe Romme Christensen, MD, PhD · Danish Multiple Sclerosis Center Rigshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-28

Primary Completion

2026-05-05

Completion

2029-05-05

Countries

• Denmark

Study Locations