Phase 3
Completed N=218
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Multiple Sclerosis, Relapsing-Remitting · Multiple Sclerosis
Source: ClinicalTrials.gov NCT02525874 ↗
Enrolled (actual)
218
Serious AEs
11.9%
Results posted
Jun 2019
Primary outcomePrimary: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) — 235.9; -18.8; -48.2; -65.9 cells per cubic millimeter (cells/mm^3)
◆ Published Evidence
Emerging
4citations · ~4 / year
Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients.
Summary
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.
Linked Publications
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Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) |
235.9; -18.8; -48.2; -65.9; -76.5; -70.1 | — |
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets |
632.6; 15.2; -26.5; -53.4; -100.4; -106.8 | — |
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets |
9.4; -1.2; -0.4; -0.4; 3.6; 2.8 | — |
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells |
14.0; 1.8; 1.8; 1.3; 2.1; 2.3 | — |
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines |
3.340; 0.090; -0.356; -0.729; -1.134; -1.511 | — |
| PRIMARY Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen |
99.33; 0.34; 0.44; 0.17; 0.19; -1.43 | — |
| SECONDARY Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks |
2116.5; -120.0; -112.8; -93.6; -101.5; -65.1 | — |
| SECONDARY Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks |
1330.1; -68.9; -23.2; -18.8; -36.9; -19.4 | — |
| SECONDARY Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks |
10.51; -0.77; -0.64; -0.44; -0.62; -0.36 | — |
| SECONDARY Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks |
542.9; -29.2; -28.5; -14.8; -3.0; -23.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
- Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]
Key Exclusion Criteria
- History of or positive test result at Screening for:
- human immunodeficiency virus
- hepatitis C virus antibody
- hepatitis B infection
- Drug or alcohol abuse within 1 year prior to Screening.
- Prior treatment with any of the following:
- cladribine
- mitoxantrone
- total lymphoid irradiation
- alemtuzumab
- T-cell or T-cell receptor vaccination
- any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
- Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
- DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
- cyclosporine
- azathioprine
- methotrexate
- mycophenolate mofetil
- intravenous (IV) Ig
- plasmapheresis or cytapheresis
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02525874) 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.