NCT04688788: DanNORMS

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

Active, enrolled Phase 3 Last updated 28 July 2025

What this trial tests

Phase 3 trial testing Rituximab in Relapsing Remitting Multiple Sclerosis in 600 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 April 2021

Primary endpoint
5 May 2026

5 May 2029

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	600
Start date	28 April 2021
Primary completion	5 May 2026
Estimated completion	5 May 2029
Sites	11 locations across Denmark

Drugs / interventions tested

• Rituximab
• Ocrelizumab (OCRELIZUMAB) — full drug profile →
• Fexofenadine (fexofenadine) — full drug profile →
• Paracetamol (Paracetamol) — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →

Conditions studied

• Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →
• Secondary Progressive Multiple Sclerosis — all drugs for Secondary Progressive Multiple Sclerosis →
• Primary Progressive Multiple Sclerosis — all drugs for Primary Progressive Multiple Sclerosis →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 65, any sex, with Relapsing Remitting Multiple Sclerosis or Secondary Progressive Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?
   Brancati S, Gozzo L, Longo L, Vitale DC, et al · · 2021 · cited 46× · PMID 34295328 · DOI 10.3389/fimmu.2021.661882
2. Drugs Targeting CD20 in Multiple Sclerosis: Pharmacology, Efficacy, Safety, and Tolerability.
   Carlson AK, Amin M, Cohen JA. · · 2024 · cited 34× · PMID 38480630 · DOI 10.1007/s40265-024-02011-w
3. Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
   Gonzalez-Lorenzo M, Ridley B, Minozzi S, Del Giovane C, et al · · 2024 · cited 17× · PMID 38174776 · DOI 10.1002/14651858.cd011381.pub3
4. What Have Failed, Interrupted, and Withdrawn Antibody Therapies in Multiple Sclerosis Taught Us?
   Krämer J, Wiendl H. · · 2022 · cited 14× · PMID 35794296 · DOI 10.1007/s13311-022-01246-3
5. Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.
   Tramacere I, Virgili G, Perduca V, Lucenteforte E, et al · · 2023 · cited 10× · PMID 38032059 · DOI 10.1002/14651858.cd012186.pub2
6. Current use of fluid biomarkers as outcome measures in Multiple Sclerosis (MS): a review of ongoing pharmacological clinical trials.
   Schilke ED, Remoli G, Funelli E, Galimberti M, et al · · 2024 · cited 7× · PMID 38117403 · DOI 10.1007/s10072-023-07228-3
7. Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis.
   Ridley B, Minozzi S, Gonzalez-Lorenzo M, Del Giovane C, et al · · 2024 · cited 6× · PMID 39254048 · DOI 10.1002/14651858.cd015443.pub2
8. The therapeutic value of treatment for multiple sclerosis: analysis of health technology assessments of three European countries.
   Gozzo L, Romano GL, Brancati S, Longo L, et al · · 2023 · cited 4× · PMID 37188269 · DOI 10.3389/fphar.2023.1169400