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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimethyl fumarate (DMF) | Experimental | Participants will receive DMF 120 mg capsules, orally, twice daily (BID) for the first 7 days, followed by 240 mg BID (maintenance dose) after 7 days for up to Week 48. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl fumarate | Drug | Administered as specified in the treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | ARR is defined as the number of confirmed MS relapses in a year. MS relapse is defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, accompanied by one or more of the following: New objective neurological findings upon examination by the treating neurologist that are functionally consistent with findings on the Expanded Disability Status Scale (EDSS) (performed within 5 days of onset of symptoms) with an increase over the prior visit of ≥0.5 for the total score, an increase of ≥2 in 1 functional system (FS), except bladder/cognitive changes, and/or an increase of ≥1 in 2 FS, except bladder/cognitive changes | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions | Week 24 | |
| Number of GdE Lesions | Week 24 and 48 | |
| Percentage of Participants GdE-Lesion Free |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | 100730 | China | |||
| Xiangya Hospital Central South University |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Week 24 and 48 |
| Percentage of Participants Relapsed | Week 48 |
| Number of New T1 Hypo-Intense Lesions | Baseline, Week 24 and 48 |
| Number of New/Newly Enlarging T2 Hyperintense Lesions | Baseline, Week 24 and 48 |
| Total T2 Lesion Volume | Week 24 and 48 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect and is a medically important event. | Up to Week 50 |
| Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs | Baseline to Week 48 |
| Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events | The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide. | Baseline to Week 48 |
| Changsha |
| 410008 |
| China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | 350005 | China |
| The Third Affiliated Hospital of Sun Yat-Sen University | Guangzhou | 510630 | China |
| The Second Hospital of Hebei Medical University | Hebei | 050004 | China |
| The First People's Hospital of Yunnan Province | Kunming | 650032 | China |
| Renji Hospital, Shanghai Jiatong Uni. School of Medicine | Shanghai | 200001 | China |
| Huashan Hospital, Fudan University | Shanghai | 200040 | China |
| The First Hospital of China Medical University | Shengyang | 110002 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | 215004 | China |
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | 30001 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 325000 | China |
| Second Affiliated Hospital of Air Force Medical University | Xi'an | 710038 | China |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |