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  2. Proyectos y Estudios
  3. Estudio de fase 3 multicéntrico, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos, seguido de una fase de tratamiento activo para evaluar la eficacia y seguridad de apremilast en niños de 2 a menos de 18 años con úlceras bucales activas asociadas a la enfermedad de Behçet (BEAN).

Estudio de fase 3 multicéntrico, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos, seguido de una fase de tratamiento activo para evaluar la eficacia y seguridad de apremilast en niños de 2 a menos de 18 años con úlceras bucales activas asociadas a la enfermedad de Behçet (BEAN).

Datos básicos

Código:
20190530
Protocolo:
20190530
EUDRACT:
2019-002787-27
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2021
Año de finalización:
2026
ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Estimar la eficacia de apremilast, en comparación con placebo, en el tratamiento de las úlceras bucales en sujetos pediátricos de 2 a < 18 años con úlceras bucales asociadas a la EB hasta la semana 12. Objetivos Secundarios: Estimar otras medidas de eficacia de apremilast para las úlceras bucales (UB) en sujetos pediátricos (2 a < 18 años); Estimar la eficacia de apremilast en el tratamiento de las úlceras genitales en sujetos pediátricos con UB; Estimar la eficacia de apremilast en la actividad global de la EB en sujetos pediátricos con UB; Estimar el efecto de apremilast en las manifestaciones de la EB (aparte de las úlceras bucales y genitales) en sujetos pediátricos con UB; Estimar el efecto de apremilast en la calidad de vida relacionada con la salud (CdVRS) en sujetos pediátricos con UB. Estimar la seguridad y la tolerabilidad de apremilast en sujetos pediátricos con UB; Describir la farmacocinética de apremilast en sujetos pediátricos con UB; Evaluar el sabor y la aceptación de las formulaciones líquidas en sujetos pediátricos con UB; Estimar un empeoramiento de la EB que requiera la administración de medicación prohibida por el protocolo en sujetos pediátricos con UB.

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

AMGEN INC

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

  • Open Access.

[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

  • Open Access.

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022


A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022


Aicardi-Goutieres syndrome type 6: report of ADAR variant and clinical outcome after ruxolitinib treatment in the neonatal period

Gabaldon-Albero, Alba; (...); Martinez, Francisco

Article. 10.1186/s12969-024-01036-5. 2024


Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital

Valero García S; (...); Poveda Andrés JL

Article. 10.1177/10781552211038518. 2021


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


Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.

Iglesias Gómez R; (...); Poveda Andrés JL

Article. 10.1136/ejhpharm-2021-002741. 2021


Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022


Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021


CLINICAL VARIABILITY IN PATIENTS DIAGNOSED OF JUVENILE IDIOPATHIC ARTHRITIS WITH POSITIVE AND NEGATIVE ANTINUCLEAR ANTIBODIES (ANA)

Torrat Noves, A. M.; (...); Roman Ivorra, J. A.

Meeting Abstract. 10.1136/annrheumdis-2023-eular.5203. 2023


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


Costs of the management of hemophilia A with inhibitors in Spain

Bonanad, S; (...); Gonzalez-Dominguez, A

Article. 10.33393/grhta.2021.2234. 2021


Current situation of osteogenesis imperfecta in Spain: results from a Delphi study

Sagastizabal, Belen; (...); Bou, Rosa

Article. 10.1186/s13023-024-03248-0. 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


Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021


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


Dual latent tuberculosis screening with tuberculin skin tests and QuantiFERON-TB assays before TNF-alpha inhibitor initiation in children in Spain.

Calzada-Hernandez, Joan; (...); Noguera-Julian, Antoni

Article. 10.1007/s00431-022-04640-3. 2022


Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021


Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Fernandez-Sanchez, M; (...); Poveda-Andres, JL

Article. 10.1002/bdr2.1942. 2021


Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024


Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022


Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022


High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.

El-Qutob D; (...); Carrera-Hueso FJ

Article. 10.1016/j.hrtlng.2022.02.003. 2022


Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies

Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo

Article. 10.7399/fh.11729. 2022


Hospitalization budget impact during the COVID-19 pandemic in Spain.

Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.

Article. 10.1186/s13561-021-00340-0. 2021


How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022


HOW TO DIAGNOSE: JUVENILE PSORIATIC ARTHRITIS. MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY IN CHILDREN WITH SUSPECTED DIAGNOSIS

Palmou-Fontana, N.; (...); Collado, P.

Meeting Abstract. 10.1136/annrheumdis-2023-eular.1883. 2023


Influence of polymorphisms in anthracyclines metabolism genes in the standard induction chemotherapy of acute myeloid leukemia.

Megías-Vericat JE; (...); Montesinos P

Article. 10.1097/FPC.0000000000000431. 2021


Inmune-mediated inflammatory rheumatic diseases in transgender people: A scoping review.

Salgado E; (...); Gomez-Reino JJ

Article. 10.1016/j.semarthrit.2021.10.004. 2022


INSIGHTS FROM A NOVEL MONOGENIC AUTOIMMUNE DISEASE: OVERVIEW OF A MULTICENTRIC EUROPEAN COHORT OF 27 PATIENTS WITH COPA SYNDROME

David-Gabarre, C.; (...); Fremond, M. L.

Meeting Abstract. 10.1136/annrheumdis-2023-eular.3505. 2023


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


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 and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial.

Jeyaratnam J; (...); Frenkel J

Article. 10.1093/rheumatology/keab696. 2021


Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis.

Brunner, Hermine I; (...); De Benedetti, Fabrizio

Article. 10.1093/rheumatology/keae180. 2024


Long-term efficacy/safety of canakinumab in patients with tumor necrosis factor receptor-associated periodic syndrome: results from a phase III trial.

Gattorno, Marco; (...); Lachmann, Helen

Article. 10.1002/art.42695. 2023


Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept.

Brunner, Hermine I; (...); Ruperto, Nicolino

Article. 10.1002/acr.25156. 2023


Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.

Megías-Vericat JE; (...); Poveda-Andrés JL

Article. 2021

  • Open Access.

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022


Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021


Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022


Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).

Valero-García S; (...); Delgado-Sánchez O

Article. 10.7399/fh.11655. 2021


Multidisciplinary consensus on the use of hydroxychloroquine in patients with systemic lupus erythematosus

Rua-Figueroa, Inigo; (...); Calvo Alen, Jaime

Article. 10.1016/j.reuma.2024.03.005. 2024


Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021


MUSCULOSKELETAL INVOLVEMENT IMPAIRS QUALITY OF LIFE IN JUVENILE PSORIATIC ARTHRITIS

Collado, P.; (...); Lopez Robledillo, J. C.

Meeting Abstract. 10.1136/annrheumdis-2023-eular.3892. 2023


National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)

Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel

Correction. 10.7399/fh.11740. 2021


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


New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024


NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases

Nadal, E.; (...); Bruna, J.

Meeting Abstract. 2022


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


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


Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022


Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021


Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

  • Open Access.

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


Pharmacokinetic, Pharmacodynamic, and Safety Profile of Subcutaneous Belimumab in Pediatric Patients with Systemic Lupus Erythematosus: Analysis of Data from a Multicenter, Open-Label Trial

Brunner, Hermine; (...); Wilde, Paul

Meeting Abstract. 2023


Pharmacometabolomics by NMR in Oncology: A Systematic Review.

Gómez-Cebrián N; (...); Pineda-Lucena A

Article. 10.3390/ph14101015. 2021


Pharmacotherapeutic management of advanced therapy medicinal products

Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia

Article. 10.7399/fh.13036. 2022


Preparation and administration of insulin infusions in neonatology: A national survey.

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Article. 10.1016/j.anpede.2020.06.015. 2021


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

  • Open Access.

Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain.

Antón J; (...); Calvo Penadés I

Article. 10.36469/001c.85088. 2023


Real-world psychosocial impact among patients with juvenile idiopathic arthritis and families in Spain

Penades, Inmaculada Calvo; (...); Anton, Jordi

Article. 10.1186/s12969-024-01035-6. 2024


Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial

Brunner, Hermine, I; (...); Ruperto, Nicolino

Article. 10.1136/ard-2022-222849. 2022


Secukinumab Treatment in Children and Adolescents with Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Efficacy and Safety Results from a Phase 3 Study

Brunner, Hermine; (...); Ruperto, Nicolino

Meeting Abstract. 2021


SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022


Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis.

Ruperto N; (...); Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Pedia

Article. 10.1093/rheumatology/keab047. 2021


Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia

Megías-Vericat JE; (...); Montesinos P

Review. 10.3390/pharmaceutics14040878. 2022


The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022


The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

Article. 10.1016/j.yebeh.2022.108711. 2022


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


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


USE OF HEALTHCARE RESOURCES AND COST ASSOCIATED RELATED TO JUVENILE IDIOPATHIC ARTHRITIS IN SPAIN: THE ITACA-OR REAL-WORLD STUDY

Peral, C.; (...); Calvo, I

Meeting Abstract. 2022


Validity and reliability of four parent/patient reported outcome measures for juvenile idiopathic arthritis remote monitoring.

van Dijkhuizen EHP; (...); Paediatric Rheumatology International Trials Organisation (PRINTO)

Article. 10.1002/acr.24855. 2022


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


What drives the decision to optimise biological treatment in children and youngsters with juvenile idiopathic arthritis? A discrete-choice experiment

Murias, Sara; (...); Anton, Jordi

Article. 10.1016/j.reuma.2021.12.003. 2023


What drives the decision to optimise biological treatment in children and youngsters with juvenile idiopathic arthritis? A discrete-choice experiment.

Murias, Sara; (...); Anton, Jordi

Article. 10.1016/j.reumae.2022.11.002. 2023


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