ENSAYOS CLÍNICOS

  • Investigador principal de 100 ensayos clínicos nacionales e internacionales

PROYECTOS DE INVESTIGACIÓN

  • 7 Proyectos FIS del Instituto de Salud Carlos III (los 5 últimos como IP)
  • 10 proyectos de Fundaciones privadas obtenidos en convocatorias competitivas (7 como IP)

PUBLICACIONES

  • 139 artículos internacionales con un factor de impacto total de 949,917 y 4.552 citaciones. Factor H= 34 (2018)
  • 38 libros y capítulos

ENSAYOS CLÍNICOS EN CURSO

Esclerosis Múltiple

  • A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.  Protocol COMB157G2102. Start year: 2019. Ongoing. PI Rafael Arroyo.
  • Multicentric, open, single-arm study, before and after change, to evaluate the efficacy, safety and tolerability of alemtuzumab in pediatric patients with RRMS. IMPLEMENTING CENTER: Hospital Universitario Quirónsalud Madrid. PI Rafael Arroyo.
  • An open- label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease- modifying treatment. Start year: 2016. Ongoing. PI Rafael Arroyo.
  • A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab administered subcutaneously versus teriflunomide administered orally in patients with relapsing forms of multiple sclerosis. Start year: 2016. Ongoing. PI Rafael Arroyo.
  • Effect of MD1003 (Biotina) in progressive multiple sclerosis: a randomized double blind placebo controlled study. Start year: 2017. Ongoing. PI Rafael Arroyo.
  • A 2-year Prospective Study to Assess Health-related quality of Life in subjects with Highly-ActiveRelapsing Multiple Sclerosis Treated with Mavenclad (Cladribine). Start year: 2018. Ongoing. PI Rafael Arroyo.
  • Phase III study: “UbLiTuximab In Multiple Sclerosis Treatment Effects”. Start year: 2018. Ongoing. PI Rafael Arroyo.

Alzheimer

  • Estudio aleatorizado, doble ciego, controlado con placebo, de dos cohortes y grupos paralelos para evaluar la eficacia de CAD106 y CNP520 en participantes con riesgo de presentar síntomas clínicos de la enfermedad de Alzheimer (EA). Generation 1. CAPI015A2201J. Inicio 2018. IP Rafael Arroyo.
  • Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de CNP520 en participantes que tienen riesgo de presentar síntomas clínicos de enfermedad de Alzheimer (EA) Generation 2. CCNP520A2202J. Inicio 2018 ongoing. IP Rafael Arroyo.
  • A Phase II, Multicenter, Randomized, Parallel Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects with Mild Cognitive Impairment due to Alzheimer’s Disease and Mild Alzheimer’s Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities. Aducanumab Study 221AD205. Start year: 2019. Ongoing. PI Rafael Arroyo.
  • A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of gantenerumab in patients with prodromal to mild alzheimer’s disease. Start year: 2018. Ongoing. PI Rafael Arroyo.
  • A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of crenezumab in patients with prodromal to mild Alzheimer’s disease. Start year: 2017. Ongoing. PI: Rafael Arroyo.
  • A placebo-controlled, double-blind, parallel-group, 24 month Study to evaluate the efficacy and safety of E2609 in subjects with early Alzheimer’s disease. Start year: 2017. Ongoing. PI: Rafael Arroyo.

Migraña

  • A 12 week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140mg AMG 334 (Erenumab)against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments. Start year: 2017. Co-Researcher Rafael Arroyo.
  • A Parallel group, double-blind, randomized, placebo controlled phase 3 Trial to Evaluate the efficacy and safety of ALD403 Administered Intravenously in patients with Chronic Migraine. Start year: 2017. Ongoing. Co-Researcher Rafael Arroyo.
  • A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for theProphylactic Treatment of Migraine in Patients with Inadequate Response to Prior Preventive Treatments. Sponsor Teva. Start year: 2018. Ongoing. Co-Researcher Rafael Arroyo

PROYECTOS DE INVESTIGACIÓN EN CURSO

  • REEM (Red Española de Esclerosis Múltiple). Patogénesis y terapia de la Esclerosis Múltiple. Entidad Financiadora: Instituto de Salud Carlos III. Subdirección General de Redes y Centros de Investigación Cooperativa. RETICS 2016. Referencia del Proyecto: RD16/0015/0013. Duración: Enero 2017-diciembre 2021 IP: Dra. Luisa María Villar Guimerans (coordinador de la Red). Investigador colaborador, Rafael Arroyo.
  • Estudio de los microRNAs de EBV, HHV-6A y HHV-6B presentes en exosomas aislados de plasma de pacientes con esclerosis múltiple: correlación con la actividad y progresión de la enfermedad. Entidad Financiadora: Fundación Ramón Areces. XVIII Concurso Nacional para la Adjudicación de Ayudas a la Investigación en Ciencias de la Vida y de la Materia. Entidades participantes: Hospital Quironsalud Madrid y Hospital Clínico San Carlos. Duración: 2017-2019. Investigador colaborador, Rafael Arroyo.
  • Vitamina D y deterioro cognitivo en la esclerosis múltiple. Entidad Financiadora: Fundación Mutua Madrileña. Entidades participantes: Hospital Quironsalud Madrid y Hospital Clínico San Carlos. Duración: 2017-2019. Investigador colaborador, Rafael Arroyo.

PUBLICACIONES INTERNACIONALES MÁS RELEVANTES

  • Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. PMID: 28002688. Factor de Impacto 2016: 72.406.
  • Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. PMID: 28002679. Factor de Impacto 2016: 72.406.
  • F, Miller DH, Freedman MS, Cree BA, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BM, Merschhemke M, Li B, Putzki N, Liu FC, Häring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double- blind, placebo-controlled trial. Lancet 2016; 387: 1075-84. Factor de impacto: 44.002.
  • Arroyo R, Sempere AP, Ruiz-Beato E, Prefasi D, Carreño A, Roset M, Maurino J. Conjoint analysis to understand preferences of patients with multiple sclerosis for disease-modifying therapy attributes in Spain: a cross-sectional observational study. BMJ Open. 2017 Mar 8;7(3):e014433. PMID: 28274968. Factor de Impacto: 2.369.
  • Fitzgerald KC, Munger KL, Hartung HP, Freedman MS, Montalbán X, Edan G, Wicklein EM, Radue EW, Kappos L, Pohl C, Ascherio A; BENEFIT Study Group. Sodium intake and multiple sclerosis activity and progression in BENEFIT. Ann Neurol. 2017 Jul;82(1):20-29. PMID: 28556498. Factor de Impacto 2016: 9.890.
  • Galan V, Casanova I, Alvarez-Lafuente R, Sanchez-Jimenez M, Garcia-Martinez MA, Dominguez-Mozo MI, Arias-Leal AM, Garcia-Montojo M, Arroyo R. Fingolimod use for the treatment of multiple sclerosis in a clinical practice setting in Madrid. Clinical Neuropharmacology 2017; 40: 29-33. Factor de impacto: 1.748.
  • Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM; BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016 Sep 6;87(10):978-87. PMID: 27511182. Factor de Impacto 2016: 8.320. 
  • Miller DH, Fox RJ, Phillips JT, Hutchinson M, Havrdova E, Kita M, Wheeler-Kingshott CA, Tozer DJ, MacManus DG, Yousry TA, Goodsell M, Yang M, Zhang R, Viglietta V, Dawson KT; CONFIRM study investigators. Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study. Neurology. 2015 Mar 17;84(11):1145-52. PMID: 25681448. Factor de Impacto 2016: 8.320.
  • Dominguez-Mozo MI, Rus M, Santiago JL, Izquierdo G, Casanova I, Galan V, Garcia-Martinez MA, Arias-Leal AM, García-Montojo M, Pérez-Pérez S, Arroyo R, Alvarez-Lafuente R. Study of the anti-JCV antibody levels in a Spanish multiple sclerosis cohort. Eur J Clin Invest. 2017 Feb;47(2):158-166. PMID: 28036121. Factor de Impacto: 2.714.
  • Fernandez O, Oterino A, Oreja-Guevara C, Prieto JM, Mendibe-Bilbao MM, Garcia-Merino JA, Ramio-Torrenta L, Ginestal R, Meca-Lallana JE, Romero-Pinel L, Munoz D, Oliva-Nacarino P, Calles-Hernandez MC, Izquierdo G, Martinez-Gines ML, Saiz A, Comabella M, Casanova-Estruch B, Brieva L, Arroyo R, Rodriguez-Antiguedad A. Review of the novelties from the 32nd ECTRIMS Congress, 2016, presented at the 9th Post-ECTRIMS Meeting (II). Rev Neurol. 2017 Jul 16;65(2):75-84. PMID: 28675259. Factor de Impacto: 0.743.
  • Fernandez O, Rodriguez-Antiguedad A, Olascoaga J, Oreja-Guevara C, Prieto JM, Mendibe-Bilbao MM, Garcia-Merino JA, Ramio-Torrenta L, Ginestal R, Meca-Lallana JE, Romero-Pinel L, Munoz D, Saiz A, Calles-Hernandez MC, Izquierdo G, Villar LM, Oliva-Nacarino P, Arnal-Garcia C, Comabella M, Brieva L, Arroyo R, Montalban X. Review of the novelties from the 31st ECTRIMS Congress, 2015, presented at the 8th Post-ECTRIMS meeting. Rev Neurol. 2016 Jun 16;62(12):559-69. PMID: 27270678. Factor de Impacto: 0.743.
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