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NCT05658484CompletedPhase 4

A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

Source: ClinicalTrials.gov · Last updated 16 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
60 (actual)
First submitted
12 Dec 2022
Start date
9 Jun 2023
Primary completion date
27 Mar 2025
Lead sponsor
Biogen
NCT number
NCT05658484

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 60
  • From 9 Jun 2023 to the primary completion date, 27 Mar 2025
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
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BeijingChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The Third Affiliated Hospital of Sun Yat-Sen University
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GuangzhouChinaUnknown status
The Second Hospital of Hebei Medical University
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HebeiChinaUnknown status
The First People's Hospital of Yunnan Province
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KunmingChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Renji Hospital, Shanghai Jiatong Uni. School of Medicine
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ShanghaiChinaUnknown status
The First Hospital of China Medical University
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ShengyangChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
The First Affiliated Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Second Affiliated Hospital of Air Force Medical University
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Xi'anChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.