Adults 18 to 65, any sex, with Multiple Sclerosis, Relapsing-Remitting or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)Primary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.
B Cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
235.9
± 168.88
B Cells: Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-18.8
± 89.71
B Cells: Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-48.2
± 122.20
B Cells: Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-65.9
± 128.53
B Cells: Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-76.5
± 140.33
B Cells: Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-70.1
± 104.80
B Cells: Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-60.7
± 115.26
NK Cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
184.2
± 107.12
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells SubsetsPrimary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell SubsetsPrimary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells \[non-class switched\], IgD- Memory B cells \[class switched\], Naïve B cells, Plasma Cells \[CD10-\], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.
CD10+ Transitional B cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
9.4
± 9.93
CD10+ Transitional B cells: Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-1.2
± 7.98
CD10+ Transitional B cells: Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.4
± 8.73
CD10+ Transitional B cells: Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.4
± 9.09
CD10+ Transitional B cells: Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
3.6
± 10.16
CD10+ Transitional B cells: Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
2.8
± 9.53
CD10+ Transitional B cells: Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
5.7
± 13.53
CD138+ Plasma Cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.26
± 0.289
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) CellsPrimary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes \[CD14+\].
CD56Bright NK cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
14.0
± 8.94
CD56Bright NK cells: Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
1.8
± 6.40
CD56Bright NK cells: Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
1.8
± 7.07
CD56Bright NK cells: Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
1.3
± 7.26
CD56Bright NK cells: Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
2.1
± 8.57
CD56Bright NK cells: Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
2.3
± 9.73
CD56Bright NK cells: Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
2.1
± 8.55
CD56Dim NK cells: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
192.9
± 130.45
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell CytokinesPrimary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at
IFNg+ (% of CD4+ T cells): Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
3.340
± 2.7365
IFNg+ (% of CD4+ T cells): Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.090
± 2.2350
IFNg+ (% of CD4+ T cells): Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.356
± 1.9676
IFNg+ (% of CD4+ T cells): Change at Week12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.729
± 2.1570
IFNg+ (% of CD4+ T cells): Change at Week24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-1.134
± 2.4239
IFNg+ (% of CD4+ T cells): Change at Week36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-1.511
± 2.5109
IFNg+ (% of CD4+ T cells): Change at Week48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-1.222
± 2.3513
IFNg+ (% of CD8+ T cells): Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
6.166
± 4.6199
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) AntigenPrimary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells \[CD11c++\]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells \[CD11c++\]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).
CD11a+ (% of B cells): Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
99.33
± 2.106
CD11a+ (% of B cells): Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.34
± 2.497
CD11a+ (% of B cells): Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.44
± 2.203
CD11a+ (% of B cells): Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.17
± 2.534
CD11a+ (% of B cells): Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
0.19
± 2.549
CD11a+ (% of B cells): Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-1.43
± 11.406
CD11a+ (% of B cells): Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.14
± 7.751
CD11a+ (% of T cells): Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
99.90
± 0.312
Change From Baseline in Immunoglobulin A (IgA) up to 48 WeeksSecondary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
2116.5
± 910.47
Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-120.0
± 231.16
Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-112.8
± 243.28
Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-93.6
± 291.76
Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-101.5
± 324.27
Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-65.1
± 279.53
Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-94.9
± 291.25
Change From Baseline in Immunoglobulin M (IgM) up to 48 WeeksSecondary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
1330.1
± 705.92
Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-68.9
± 214.07
Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-23.2
± 208.48
Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-18.8
± 270.82
Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-36.9
± 293.14
Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-19.4
± 406.86
Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-96.8
± 236.48
Change From Baseline in Immunoglobulin G (IgG) up to 48 WeeksSecondary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
10.51
± 2.328
Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.77
± 1.039
Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.64
± 1.077
Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.44
± 1.187
Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.62
± 1.324
Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.36
± 1.025
Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.53
± 1.142
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 WeeksSecondary· Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
IgG Subclass 1: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
542.9
± 152.87
IgG Subclass 1: Change at Week 4
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-29.2
± 68.22
IgG Subclass 1: Change at Week 8
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-28.5
± 71.46
IgG Subclass 1: Change at Week 12
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-14.8
± 79.07
IgG Subclass 1: Change at Week 24
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-3.0
± 78.80
IgG Subclass 1: Change at Week 36
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-23.1
± 61.73
IgG Subclass 1: Change at Week 48
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
-0.5
± 102.41
IgG Subclass 2: Baseline
Group
Value
95% CI
Dimethyl Fumarate (BG00012)
350.7
± 116.43
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 33 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dimethyl Fumarate (BG00012)
Serious: 26/218 (12%)
Deaths: 0/218
Serious adverse events (16 terms)
Reaction
System
Dimethyl Fumarate (BG00012)
Multiple sclerosis relapse
Nervous system disorders
—
Acute myocardial infarction
Cardiac disorders
—
Iridocyclitis
Eye disorders
—
Non-cardiac chest pain
General disorders
—
Cholecystitis chronic
Hepatobiliary disorders
—
Cellulitis
Infections and infestations
—
Nasopharyngitis
Infections and infestations
—
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
—
Diabetic ketoacidosis
Metabolism and nutrition disorders
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Breast cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06850597 — Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's D
· Phase 2
· recruiting
NCT02969304 — Study of Utilization Patterns of Dimethyl Fumarate in Germany
· completed
NCT02555215 — Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
· Phase 3
· completed
NCT02471560 — Tecfidera and the Gut Microbiota
· Phase 4
· completed
NCT02410200 — Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
· Phase 2
· completed
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap
· Phase 3
· recruiting
NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
· NA
· recruiting
NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
· NA
· recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
· active not recruiting
NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
· NA
· recruiting
Other Biogen trials
Trials by the same sponsor.
NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses
· Phase 3
· not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri
· recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy
· Phase 3
· not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants
· Phase 3
· not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 27 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02525874.