Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Recruiting NCT04121065 - Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
Active, not recruiting NCT03996291 - Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis Phase 2
Recruiting NCT04510220 - 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis Phase 3
Terminated NCT02241785 - Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies Phase 4
Completed NCT02792218 - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis Phase 3
Completed NCT01412333 - A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis Phase 3
Completed NCT03257358 - A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod Phase 4
Completed NCT01628393 - Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients Phase 2/Phase 3
Completed NCT04626921 - A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis Phase 2/Phase 3
Withdrawn NCT02234869 - Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy Phase 4
Withdrawn NCT05077956 - Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Active, not recruiting NCT04486716 - A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis Phase 3
Recruiting NCT04121403 - Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) Phase 3
Recruiting NCT05809986 - Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Terminated NCT00988052 - A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course Phase 3
Active, not recruiting NCT05232825 - A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis Phase 3
Terminated NCT01047319 - A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis Phase 3
Completed NCT04847596 - A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Completed NCT01006941 - Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study Phase 2
Completed NCT01127750 - Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients Phase 3