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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003282-29 | EudraCT Number |
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The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate | Experimental | Participants will receive 120 mg capsule(s) taken orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. 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 (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. | Baseline to Week 96 |
| Number of Participants Discontinuing Treatment Due to an Adverse Event | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. | Baseline to Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24 | T2 hyperintense lesions were measured by MRI brain scans. | Week 16 to Week 24 |
| Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72 |
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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 |
|---|---|---|---|---|---|---|
| Research Site | Loma Linda | California | 92354 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dimethyl Fumarate | Participants will receive 120 mg capsule(s) taken orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2018 | Sep 23, 2019 |
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T2 hyperintense lesions were measured by MRI brain scans. |
| Week 64 to Week 72 |
| Average Annualized Relapse Rate (ARR) | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively. | Baseline to Week 96 |
| Percentage of Participants Experiencing One or More Relapses | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. | Baseline to Week 96 |
| Change From Baseline in the Degree of Disability | The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. | Baseline to Week 96 |
| Number of Participants Experiencing Disability Progression | Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks. | Baseline to Week 96 |
| Ghent |
| 9000 |
| Belgium |
| Research Site | Sofia | 1113 | Bulgaria |
| Research Site | Hradec Králové | 50333 | Czechia |
| Research Site | Munich | Bavaria | 80337 | Germany |
| Research Site | Göttingen | Lower Saxony | 37075 | Germany |
| Research Site | Kuwait City | 15462 | Kuwait |
| Research Site | Riga | LV-1004 | Latvia |
| Research Site | Beirut | 1107 2020 | Lebanon |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Poznan | 60-355 | Poland |
| Research Site | Ankara | 06100 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dimethyl Fumarate | Participants will receive 120 mg capsule(s) taken orally. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. 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 (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. | The safety population was defined as all participants who received at least 1 dose of BG00012. | Posted | Number | participants | Baseline to Week 96 |
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| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Discontinuing Treatment Due to an Adverse Event | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. | Posted | Number | participants | Baseline to Week 96 |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24 | T2 hyperintense lesions were measured by MRI brain scans. | Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis. | Posted | Count of Participants | Participants | Week 16 to Week 24 |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72 | T2 hyperintense lesions were measured by MRI brain scans. | Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis. | Posted | Count of Participants | Participants | Week 64 to Week 72 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Average Annualized Relapse Rate (ARR) | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively. | Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis. | Posted | Number | relapses per person-years | Baseline to Week 96 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing One or More Relapses | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. | Posted | Number | percentage of participants | Baseline to Week 96 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Degree of Disability | The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. | Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 96 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Disability Progression | Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks. | Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis. | Posted | Count of Participants | Participants | Baseline to Week 96 |
|
|
Baseline to Week 96
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BG00012 | Participants will receive 120 mg capsule(s) taken orally. | 0 | 20 | 2 | 20 | 18 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Wolff-parkinson-white syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Dust allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Smoke sensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Mastoiditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Root canal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Salpingo-oophoritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Demyelination | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Somatic symptom disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Uterine inflammation | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Overall Study Officials | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2018 | Sep 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| White |
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| Not Reported Due to Confidentiality Regulations |
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| Other |
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| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 0 lesions |
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| 1 lesion |
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| 2 lesions |
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| 3 lesions |
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| 4 lesions |
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| 5 or more lesions |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 0 lesions |
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| 1 lesion |
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| 2 lesions |
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| 3 lesions |
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| 4 lesions |
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| 5 or more lesions |
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