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BG00012

DRUG6 trials

Sponsors

Biogen

Conditions

HealthyMultiple SclerosisRelapsing Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisRheumatoid Arthritis

Phase 1

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
CompletedNCT00837785
BiogenRelapsing Remitting Multiple Sclerosis
Start: 2009-02-28End: 2009-10-31Updated: 2018-02-15
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
CompletedNCT01069913
BiogenHealthy
Start: 2009-10-31End: 2010-01-31Updated: 2010-02-17

Phase 2

Efficacy and Safety of BG00012 in MS
CompletedNCT00168701
BiogenMultiple Sclerosis
Start: 2004-10-01End: 2006-03-31Updated: 2023-08-28
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
CompletedNCT00810836
BiogenRheumatoid Arthritis
Start: 2008-12-31End: 2010-03-31Updated: 2013-09-16

Phase 3

Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
CompletedNCT00420212
BiogenRelapsing-Remitting Multiple Sclerosis
Start: 2007-01-31End: 2011-02-28Updated: 2015-01-26
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
CompletedNCT00451451
BiogenRelapsing-Remitting Multiple Sclerosis
Start: 2007-06-30End: 2011-08-31Updated: 2015-01-26

Related Papers

Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies.
2023-04-155 citations
Effectiveness of Dimethyl Fumarate in Patients With Relapsing Multiple Sclerosis Switching After Suboptimal Response to Glatiramer Acetate, Including Patients With Early Multiple Sclerosis: Subgroup Analysis of RESPOND
Neurology and Therapy2020-11-236 citations
Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE
Therapeutic Advances in Neurological Disorders2020-01-0151 citations
Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing–remitting multiple sclerosis in a real-world clinical setting: PROTEC
Multiple Sclerosis Journal - Experimental Translational and Clinical2019-10-0120 citations
Effect of dimethyl fumarate on lymphocytes in RRMS
Neurology2019-03-2879 citations
Data from: Effect of dimethyl fumarate on lymphocytes in RRMS: implications for clinical practice
DRYAD2018-11-19
Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM.
2017-08-0215 citations
Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM.
2017-07-2522 citations
Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis.
2016-11-1029 citations
Comparing outcomes from clinical studies of oral disease-modifying therapies (dimethyl fumarate, fingolimod, and teriflunomide) in relapsing MS: Assessing absolute differences using a number needed to treat analysis.
2016-11-0326 citations
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
Neurology and Therapy2016-03-0139 citations
Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies.
2015-10-316 citations
Assessing Comparative Outcomes from Teriflunomide and Dimethyl Fumarate Studies in Relapsing MS: Use of “Number Needed to Treat” Analysis (P3.245)
Neurology2015-04-062 citations
Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies.
2014-10-1228 citations
BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety.
2013-10-2282 citations
Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.
2012-09-011277 citations
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
2012-09-011002 citations
Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
2008-10-01337 citations