Trial reportJournal of neurology2014
Magnetization transfer ratio in the delayed-release dimethyl fumarate DEFINE study.
Trial report in Journal of neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Ocrelizumab-treated patients with relapsing multiple sclerosis show volume loss rates similar to healthy aging.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023Trial
- Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Trial
- Advanced MRI Techniques: Diagnosis and Follow-Up of Multiple Sclerosis.Diagnostics (Basel, Switzerland) · 2024Review
- The Two Sides of Siponimod: Evidence for Brain and Immune Mechanisms in Multiple Sclerosis.CNS drugs · 2022Review
- Quantitative magnetization transfer imaging in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis.Brain communications · 2022Review
- Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015-2020.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Current Landscape of NRF2 Biomarkers in Clinical Trials.Antioxidants (Basel, Switzerland) · 2020Review
- Magnetization transfer ratio quantifies polyneuropathy in hereditary transthyretin amyloidosis.Annals of clinical and translational neurology · 2020Article
- Review
- Identification of Novel Protein Targets of Dimethyl Fumarate Modification in Neurons and Astrocytes Reveals Actions Independent of Nrf2 Stabilization.Molecular & cellular proteomics : MCP · 2019Article
- Clinical evaluation of dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis: efficacy, safety, patient experience and adherence.Patient preference and adherence · 2019Article
- Advances in brain imaging in multiple sclerosis.Therapeutic advances in neurological disorders · 2019Review
- Dimethyl fumarate mitigates optic neuritis.Molecular vision · 2019Article
- Magnetic Resonance Imaging in Multiple Sclerosis.Cold Spring Harbor perspectives in medicine · 2018Review
- Future Brain and Spinal Cord Volumetric Imaging in the Clinic for Monitoring Treatment Response in MS.Current treatment options in neurology · 2018Review
- Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting.Nature reviews. Neurology · 2018Review
- The Role of Advanced Magnetic Resonance Imaging Techniques in Multiple Sclerosis Clinical Trials.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017Review
- Assessing Repair in Multiple Sclerosis: Outcomes for Phase II Clinical Trials.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017Review
- Effects of fumarates on inflammatory human astrocyte responses and oligodendrocyte differentiation.Annals of clinical and translational neurology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We measured changes in brain magnetization transfer ratio (MTR) as a potential indicator of myelin density in brain tissue of patients with relapsing-remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) in the Phase 3 DEFINE study. DEFINE was a randomized, double-blind, placebo-controlled study in which patients with RRMS were randomized 1:1:1 to 2 years of treatment with delayed-release DMF 240 mg twice daily (BID) or three times daily (TID) or placebo. MTR was analyzed in whole brain and normal-appearing brain tissue (NABT) at baseline, week 24, 1 year, and 2 years in a subset of patients. MTR data from 392 patients were analyzed. Mean percentage reduction from baseline to 2 years in median whole brain MTR was -0.386% in the placebo group vs increases of 0.129% (p = 0.0027) and 0.096% (p = 0.0051) in the delayed-release DMF BID and TID groups, respectively. Similarly, mean percentage reduction from baseline in median NABT MTR was -0.392% with placebo vs increases of 0.190% (p = 0.0006) and 0.115% (p = 0.0029) with delayed-release DMF BID and TID, respectively. Post hoc analysis of data from patients with no new or enlarging T2 lesions (n = 147), or who experienced no relapses (n = 238), yielded similar results. In this analysis, increases in MTR in brain tissue most likely reflect increases in myelin density in response to delayed-release DMF. These data in patients with RRMS are consistent with preclinical studies that indicate a potential for cytoprotection and remyelination with delayed-release DMF treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.