A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
Dimethyl fumarate
Autoimmune Diseases+4
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: June 9, 2023
Actual date on which the first participant was enrolled.The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria: * Must have a baseline (pre-dose on Day 1) Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive. * Must have experienced at least 1 documented relapse within the 12 months before screening, with a prior brain magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brain on an MRI performed within the 6 weeks prior to screening. Key Exclusion Criteria: * An MS relapse that occurred within the 30 days prior to screening and/or the participant has not stabilized from a previous relapse prior to screening. * Current hepatitis C infection and current hepatitis B infection. Participants with immunity to hepatitis B from previous natural infection or vaccination are eligible to participate in the study. * History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the Investigator, are likely to be exacerbated by any component of the study treatment. * History or positive test result at screening for human immunodeficiency virus (HIV). * Use at the time of enrollment and/or anticipated ongoing use of any traditional and/or unlicensed medicines and/or traditional therapies and/or herbal preparations, which are known or considered by the Investigator to affect MS and endpoints that are being considered in the study, including safety and efficacy. * Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Xiangya Hospital Central South University
Changsha, ChinaWest China Hospital of Sichuan University
Chengdu, ChinaThe First Affiliated Hospital of Fujian Medical University
Fuzhou, China