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Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China

Relapsing Multiple Sclerosis Clinical Trial

Official title:
A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.

Clinical Trial Description

This study consists of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It is an open-label single-arm study so all participants will receive the study drug. The first dose will be administered in the clinic and the remaining doses may be administered at home. The doses are administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4. Participants will be required to come into the clinic for one screening visit, and 5 visits during the Treatment period for clinical evaluation and lab tests. Participants who complete the 12-month treatment will have Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decide to continue with commercially available ofatumumab treatment outside of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05199571
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 4
Start date July 22, 2022
Completion date March 21, 2025
View Details
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