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- Proyectos y Estudios
- Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, con doble simulación, controlado con tratamiento activo y comparativo para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ponesimod frente a fingolimod durante 108 semanas de tratamiento en pacientes pediátricos, de 10 a
Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, con doble simulación, controlado con tratamiento activo y comparativo para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de ponesimod frente a fingolimod durante 108 semanas de tratamiento en pacientes pediátricos, de 10 a <18 años, con esclerosis múltiple remitente recurrente.
Datos básicos
- Protocolo:
- 67896153MSC3001
- EUDRACT:
- 2020-004431-24
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: El objetivo primario es demostrar que ponesimod no es menos eficaz que fingolimod en la reducción de las recaídas en pacientes pediátricos con esclerosis múltiple remitente recurrente (EMRR) si el tratamiento se toma según las indicaciones hasta la semana 108. Objetivos Secundarios: Los objetivos secundarios son: ?Evaluar el efecto de ponesimod frente a fingolimod en la TRA en pacientes pediátricos con EMRR, determinado por el cociente de tasas de ponesimod frente a fingolimod. ?Evaluar el efecto de ponesimod en la acumulación de discapacidad de la EM y en la acumulación de lesiones por resonancia magnética (RM) en comparación con fingolimod en pacientes pediátricos con EMRR. •Evaluar la seguridad, tolerabilidad y farmacodinamia (FD) de ponesimod en comparación con fingolimod en pacientes pediátricos con EMRR. •Evaluar la farmacocinética (FC) de ponesimod en pacientes pediátricos con EMRR •Estudiar la relación FD/FC en cuanto a los resultados clave de eficacia y seguridad en pacientes pediátricos con EMRR tratados con ponesimod.
Documentos
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Participantes
Grupos
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Resultados del Ensayo Clínico
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
Acute calcareous corneal degeneration in a patient with chronic graft-versus-host disease.
Ruiz, Marta Gema Solaz; (...); Gregori, Enrique Espana
Review. 10.22336/rjo.2024.10. 2024
An algorithm to predict intrathecal synthesis of IgG with high efficiency
Tortosa-Carreres, Jordi; (...); Casanova, Bonaventura
Meeting Abstract. 2023
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Assessment of Plasma and Cerebrospinal Fluid Biomarkers in Different Stages of Alzheimer's Disease and Frontotemporal Dementia.
Álvarez-Sánchez L; (...); Cháfer-Pericás C
Article. 10.3390/ijms24021226. 2023
Assessment of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and other antidiabetic agents in Alzheimer's disease: A population-based study.
Zamora MG; (...); Pericas CC
Article. 10.1016/j.phrs.2024.107295. 2024
Association of Complement Factors With Disability Progression in Primary Progressive Multiple Sclerosis.
Lunemann JD; (...); Comabella M
Article. 10.1212/NXI.0000000000200270. 2024
Association of Serum Neurofilament Light Chain Levels at Disease Onset With Disability Worsening in Patients With a First Demyelinating Multiple Sclerosis Event Not Treated With High-Efficacy Drugs.
Monreal, Enric; (...); Villar LM
Article. 10.1001/jamaneurol.2023.0010. 2023
Associations between antidiabetic medications and cerebrospinal fluid biomarkers of Alzheimer's disease.
Garcia-Lluch, Gemma; (...); Chafer-Pericas, Consuelo
Article. 10.1177/13872877241304995. 2024
Autologous hematopoietic stem cell transplantation in multiple sclerosis: updating outcomes in the Valencian cohort.
Boix Lago, A.; (...); Casanova Estruch, B.
Meeting Abstract. 2023
Cardiovascular Risk Scales Association with Cerebrospinal Fluid Alzheimer's Disease Biomarkers in Cardiovascular Low Cardiovascular Risk Regions.
García-Lluch G; (...); Cháfer-Pericás C
Article. 10.14283/jpad.2024.16. 2024
Clinical characteristics and impact on patient-reported outcomes and quality of life of people with ambulatory secondary progressive multiple sclerosis: DISCOVER study
Oreja-Guevara, Celia; (...); Rio, Jordi
Article. 10.1016/j.msard.2024.105787. 2024
Clinical trajectories of patients with multiple sclerosis from onset and their relationship with serum neurofilament light chain levels
Quintanilla-Bordas, Carlos; (...); Casanova, Bonaventura
Article. 10.3389/fneur.2024.1477335. 2024
Comparative Assessment of Simoa and Lumipulse for Measuring Serum Neurofilament Light Chain in Multiple Sclerosis Patients
Gasque-Rubio, Raquel; (...); Perez-Miralles, Francisco
Article. 10.1155/2024/1950913. 2024
Comparison of different agents and doses of anti-vascular endothelial growth factors (aflibercept, bevacizumab, conbercept, ranibizumab) versus laser for retinopathy of prematurity: A network meta-analysis.
Ortiz-Seller, Amparo; (...); Ortiz, Jose L.
Article. 10.1016/j.survophthal.2024.02.005. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Childhood-Onset Non-Infectious Uveitis in the "Biologic Era". Results From Spanish Multicenter Multidisciplinary Real-World Clinical Settings.
Mesa-Del-Castillo P; (...); Sánchez Sevila JL
Article. 10.1080/09273948.2024.2336609. 2024
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Does benign multiple sclerosis exist?
Verdini Martinez, Laura; (...); Casanova, Bonaventura
Meeting Abstract. 2023
Dynamic 18F-FDG PET to detect differences among patients with progressive and relapsing multiple sclerosis: a pilot study
Quintanilla Bordas, Carlos; (...); Casanova, Bonaventura
Meeting Abstract. 2023
Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers
Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo
Article. 10.3390/ijms241814151. 2023
Early beginning of alemtuzumab: Changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study.
Meca-Lallana, J E; (...); Calles Hernandez, C
Article. 10.1016/j.nrleng.2021.06.006. 2023
Early beginning of alemtuzumab: changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study
Meca-Lallana, J. E.; (...); Hernandez, C. Calles
Article. 10.1016/j.nrl.2021.06.007. 2024
Eculizumab for a catastrophic relapse in NMOSD: case report.
Gorriz, David; (...); Casanova, Bonaventura
Article. 10.1007/s10072-023-06971-x. 2023
Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.
Meca-Lallana JE; (...); Llarena C
Article. 10.1007/s40120-023-00557-7. 2023
Elevation of serum neurofilament light-chain levels disclose possible occult progressive multifocal leukoencephalopathy and immune reconstitution syndrome in a patient receiving ozanimod: a case report.
Quintanilla-Bordás C; (...); Pérez-Miralles FC
Case Reports. 10.3389/fimmu.2024.1465678. 2024
Emotion recognition and baseline cortisol levels relationship in early Alzheimer Disease.
Ferrer-Cairols, I.; (...); Chafer-Pericas, C.
Article. 10.1016/j.biopsycho.2023.108511. 2023
Evaluating the complement C1q levels in serum and cerebrospinal fluid in multiple sclerosis patients: Could it serve as a valuable marker in clinical practice?
Tortosa-Carreres J; (...); Pérez-Miralles FC
Article. 10.1016/j.jneuroim.2024.578428. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Improvements in Quality of Life of Patients with Multiple Sclerosis receiving Alemtuzumab in Clinical Practice: LEMVIDA study
Meca Lallana, Jose; (...); Forner, Mireia
Meeting Abstract. 10.1212/WNL.0000000000202381. 2023
Improvements in quality of life of patients with multiple sclerosis receiving alemtuzumab in clinical practice: the LEMVIDA study.
Meca-Lallana, Jose Eustasio; (...); Toledo, Baldo
Article. 10.1186/s41687-024-00822-9. 2024
Improving the efficiency of free kappa light chains as diagnostic biomarker of Multiple Sclerosis by using a novel algorithm.
Tortosa-Carreres J; (...); Pérez-Miralles FC
Article. 10.1016/j.msard.2023.104997. 2023
Increased EBNA1-specific antibody response in primary-progressive multiple sclerosis
Comabella, Manuel; (...); Luenemann, Jan D.
Article. 10.1007/s00415-024-12763-w. 2025
Influence of Statin Potency and Liposolubility on Alzheimer's disease patients: a population-based study.
Garcia-Zamora, Mar; (...); Chafer-Pericas, Consuelo
Article. 10.1016/j.phrs.2024.107446. 2024
Insights from a 7-Year Dementia Cohort (VALCODIS): ApoE Genotype Evaluation.
Baquero, Miguel; (...); Chafer-Pericas, Consuelo
Article. 10.3390/jcm13164735. 2024
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Is it cost-effective to request IgM oligoclonal bands against lipids in daily practice as a biomarker for poor prognosis in multiple sclerosis?
Ribes Garcia, Sara; (...); Bonaventura, Casanova Estruch
Article. 10.1016/j.msard.2023.105033. 2023
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Long-term efficacy of alemtuzumab in multiple sclerosis: a real word multicenter Spanish experience
Rubio Alcantud, Almudena; (...); Casanova, Bonaventura
Meeting Abstract. 2023
Megaconial congenital muscular dystrophy: Importance of cutaneous features and successful response to ustekinumab.
Palacios-Diaz RD; (...); Évole-Buselli M
Article. 10.1111/pde.15716. 2024
miRNA Signature in CSF From Patients With Primary Progressive Multiple Sclerosis.
Munoz-San Martin, Maria; (...); Ramio-Torrenta, Lluis
Article. 10.1212/NXI.0000000000200069. 2023
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
Neuromyelitis optica associated with the use of Atezolizumab in a patient with advanced lung adenocarcinoma.
Pedrero Prieto, Manuel; (...); Casanova Estruch, Bonaventura
Article. 10.1007/s10072-023-07252-3. 2023
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Oligoclonal M bands and cervical spinal cord lesions predict early secondary progressive multiple sclerosis.
Alcala Vicente, Carmen; (...); Casanova, Bonaventura
Article. 10.3389/fneur.2022.991596. 2022
Oligoclonal M bands distinguish two MS populations based on neurofilament light chain levels in patients without inflammatory activity
Castillo, J.; (...); Casanova, B.
Meeting Abstract. 2022
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Predictive potential of serum and cerebrospinal fluid biomarkers for disease activity in treated multiple sclerosis patients.
Tortosa-Carreres J; (...); Pérez-Miralles FC
Article. 10.1016/j.msard.2024.105734. 2024
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Renal function influences serum neurofilament light chain levels in patients with multiple sclerosis
Gasque Rubio, R.; (...); Casanova Estruch, B.
Meeting Abstract. 2022
Renal function's impact on serum neurofilament levels in patients with multiple sclerosis: an exploratory analysis.
Tortosa-Carreres, Jordi; (...); Perez-Miralles, Francisco
Article. 10.1007/s10072-024-07772-6. 2024
Response to letter to the editor: An in-depth look at the relationship between anti-diabetic drugs and Alzheimer's disease.
Garcia-Zamora, Mar; (...); Pardo Albiach, Juan
Letter. 10.1016/j.phrs.2024.107396. 2024
Response to letter to the editor: Expanding perspectives on the relationship between statin potency and lipophilicity in Alzheimer's disease management.
Garcia-Zamora, Mar; (...); Pardo, Juan
Letter. 10.1016/j.phrs.2025.107595. 2025
Selecting a Brief Cognitive Screening Test Based on Patient Profile: It Is Never Too Early to Start
Garcia-Lluch, Gemma; (...); Moreno, Lucrecia
Article. 10.3390/jcm13196009. 2024
Serum biomarker levels predict disability progression in patients with primary progressive multiple sclerosis.
Fissolo, Nicolas; (...); Comabella, Manuel
Article. 10.1136/jnnp-2023-332251. 2023
Serum biomarkers at disease onset for personalized therapy in multiple sclerosis.
Monreal E; (...); Villar LM
Article. 10.1093/brain/awae260. 2024
Serum Glial Fibrillary Acidic Protein and Neurofilament Light Chain Levels at Disease Onset for Prediction of the Risk of Disability Worsening in Patients with Multiple Sclerosis
Monreal, Enric; (...); Villar Guimerans, Luisa Maria
Meeting Abstract. 2023
Serum neurofilament light chain and glial fibrillary acidic protein levels at disease onset unveil immunological pathways of disability acquisition in multiple sclerosis
Monreal, Enric; (...); Villar Guimerans, Luisa Maria
Meeting Abstract. 2024
Serum Neurofilament Light Chain is a surrogate marker of NEDA-3 in Multiple Sclerosis
Gascon Gimenez, Francisco Guillermo; (...); Casanova, Bonaventura
Meeting Abstract. 2023
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxicity to intravitreal melphalan in a patient with retinoblastoma.
Solaz-Ruiz, Marta Gema; (...); Espana-Gregori, Enrique
Case Reports. 10.22336/rjo.2023.49. 2023
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Treatment of multiple sclerosis with rituximab: A Spanish multicenter experience.
Gascon-Gimenez, Francisco; (...); Casanova, Bonaventura
Article. 10.3389/fneur.2023.1060696. 2023
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023