Phase 3
Completed N=1,736
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT00835770 ↗Enrolled (actual)
1,736
Serious AEs
31.7%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) — 824; 814 Participants
◆ Published Evidence
Established
81citations · ~12 / year
Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice.
Summary
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Linked Publications (4)
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Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice.
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Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE.
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Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies.
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Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) |
824; 814 | — |
| SECONDARY Percentage of Participants Who Had Relapses |
40; 41; 34; 36; 31; 31 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.159; 0.179; 0.200; 0.199; 0.184; 0.212 | — |
| SECONDARY Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 |
2.44; 2.43; 2.50; 2.54; 2.57; 2.68 | — |
| SECONDARY Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) |
0.4; 0.4; 0.2; 0.3; 0.5; 0.4 | — |
| SECONDARY Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) |
31.7; 48.6; 96.0; 142.5; 37.1; 41.7 | — |
| SECONDARY Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) |
1.6; 2.2; 2.7; 2.4; 3.4; 2.1 | — |
| SECONDARY Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) |
10231.9; 10408.3; 8883.7; 10806.3; 12628.9; 13044.4 | — |
| SECONDARY Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) |
0.8; 1.0; 1.8; 1.7; 2.0; 1.3 | — |
| SECONDARY Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) |
3640.1; 3447.3; 2754.2; 3623.1; 3204.3; 3572.6 | — |
| SECONDARY Percent Change From Baseline in Brain Atrophy |
-1.206; -1.263; -1.487; -1.320; -1.496; -1.414 | — |
| SECONDARY Percent Change From Baseline in Magnetization Transfer Ratio (MTR) |
-0.325; -0.383; 1.034; -0.567; -0.081; -0.334 | — |
| SECONDARY Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 |
68.48; 71.78; 69.67; 67.97; 69.10; 68.20 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 |
0.73; 0.73; 0.72; 0.71; 0.71; 0.72 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 |
70.97; 70.48; 70.40; 69.44; 66.80; 69.07 | — |
| SECONDARY Change From Baseline in Visual Function Test Scores at Week 384 |
54.7; 55.0; 55.1; 54.8; 54.3; 55.0 | — |
Eligibility Criteria
Key Inclusion Criteria
-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
Key Exclusion Criteria
- Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00835770) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.