drugset / Trial / NCT04788615

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

NCT04788615

Phase 3 Completed 185 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

Timeline

Start
2021-07-23
Primary completion
2025-11-04
Completion
2025-11-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diroximel fumarate Small molecule 231 mg
Comparator Diroximel fumarate Small molecule 462 mg
Comparator Glatiramer Acetate Small molecule 20 mg
Comparator Glatiramer Acetate Small molecule 40 mg
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous
Comparator Teriflunomide Small molecule 14 mg
Comparator dimethyl fumarate Unknown 120 mg
Comparator dimethyl fumarate Unknown 240 mg
Comparator peginterferon beta-1a Protein / enzyme biologic 63 ug
Comparator peginterferon beta-1a Protein / enzyme biologic 125 ug

Indications