A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, WITHDRAWAL, SAFETY AND EFFICACY STUDY OF ORAL BARICITINIB IN PATIENTS FROM 2 YEARS TO LESS THAN 18 YEARS OLD WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA).
Datos básicos
- Código:
- I4V-MC-JAHV
- Protocolo:
- I4V-MC-JAHV
- EUDRACT:
- 2017-004518-24
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2019
- Año de finalización:
- 2021
Documentos
- No hay documentos
Participantes
Resultados del Ensayo Clínico
2019 SEFH National Survey: service portfolio, care activities, education and research in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11611. 2021
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 Multiple Stakeholder Multicriteria Decision Analysis in Diabetic Macular Edema Management: The MULTIDEX-EMD Study.
de Andrés-Nogales F; (...); Martínez-Olmos J
Article. 10.1007/s41669-020-00201-2. 2020
A new definition and refocus of pharmaceutical care: the Barbate Document
Morillo-Verdugo R; (...); Poveda-Andrés JL
Article. 10.7399/fh.11389. 2020
Adherence and adverse events of intraperitoneal chemotherapy in optimally debulked ovarian cancer patients: Real-life study.
Ballesta-López O; (...); Poveda-Andrés JL
Article. 10.1177/1078155220915953. 2020
Analysing criteria for price and reimbursement of orphan drugs in Spain.
Badia, X; (...); Tort, M
Article. 10.7399/fh.11147. 2019
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- Citations
- Citation Indexes: 11
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- Full Text Views: 375
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- Readers: 57
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
Anti-IL6-Receptor Tocilizumab in Refractory and Noninfectious Uveitic Cystoid Macular Edema: Multicenter Study of 25 Patients
Vegas-Revenga, N; (...); Blanco, R
Article. 10.1016/j.ajo.2018.12.019. 2019
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
CASE-REVIEW ON FAMILIAL MEDITERRANEAN FEVER IN A SPECIALIZED CENTRE
Sobrin, RD; (...); Calvo, I.
Meeting Abstract. 10.1136/annrheumdis-2020-eular.1355. 2020
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 pharmacy services: from cost-effectiveness analysis to a productivity indicators model
Nogueras, A; (...); Calleja, MA
Letter. 10.1136/ejhpharm-2019-001905. 2019
Comparison of pharmacokinetic estimates using generic and specific population pharmacokinetic models of plasma-derived factor VIII/VWF using WAPPS-Hemo
Megias-Vericat, JE; (...); Poveda, JL
Meeting Abstract. 2020
COST MINIMIZATION ANALYSIS OF RITUXIMAB BIOSIMILAR VERSUS REFERENCE RITUXIMAB IN THE TREATMENT OF FOLLICULAR LYMPHOMA
Gironella, M.; (...); Oyaguez, I
Meeting Abstract. 2019
Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain.
Poveda JL; (...); Torres C
Article. 10.1080/14737167.2019.1635014. 2020
COSTS OF THE MANAGEMENT OF HEMOPHILIA A WITH INHIBITORS IN SPAIN
Bonanad, S; (...); Gonzalez-Dominguez, A
Meeting Abstract. 2020
Costs of the management of hemophilia A with inhibitors in Spain
Bonanad, S; (...); Gonzalez-Dominguez, A
Article. 10.33393/grhta.2021.2234. 2021
Cross-Sectional Comparative Study of PK-Guided Switch between Standard Half-Life and Extended Half-Life Factor VIII Products
Eduardo Megias, Juan; (...); Iorio, Alfonso
Meeting Abstract. 10.1182/blood-2019-127946. 2019
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 the value contribution of emicizumab (Hemlibra (R)) for the prophylaxis of haemophilia A with inhibitors in Spain by multi-criteria decision analysis
Alvarez-Roman, MT; (...); Badia, X
Article. 10.1177/2284240319880534. 2019
DETERMINING THE VALUE OF EMICIZUMAB FOR THE PROPHYLAXIS OF SEVERE HAEMOPHILIA A PATIENTS WITHOUT INHIBITORS IN SPAIN BY MULTI-CRITERIA DECISION ANALYSIS (MCDA)
Alvarez, E.; (...); Badia, F. J.
Meeting Abstract. 2019
DEVELOPMENT AND VALIDATION OF A MCDA FRAMEWORK FOR EVALUATION AND DECISION-MAKING OF ORPHAN DRUGS IN SPAIN
Poveda, J. L.; (...); Vitoria, I
Meeting Abstract. 2019
Development and validation of an MCDA framework for evaluation and decision-making of orphan drugs in Spain
Badia, X; (...); Poved, JL
Article. 10.1080/21678707.2019.1652163. 2019
Documento español de consenso sobre diagnóstico, estabilización y tratamiento del síndrome inflamatorio multisistémico pediátrico vinculado a SARS-CoV-2 (SIM-PedS).
García-Salido A; (...); Villalobos Pinto E
Article. 10.1016/j.anpedi.2020.09.005. 2021
Efecto de la adición de fortificantes y de módulo de proteínas en la osmolalidad de la leche materna donada.
Torres Martínez E; (...); Vento M
Article. 10.1016/j.anpedi.2020.03.009. 2020
Effect of Immunogenicity on Efficacy and Safety of Subcutaneous or Intravenous Abatacept in Pediatric Patients with Polyarticular-Course JIA: Findings from Two Phase III Trials
Brunner, Hermine; (...); Ruperto, Nicolino
Meeting Abstract. 2019
Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment
Palanques-Pastor T; (...); Poveda Andrés JL
Article. 10.1159/000517813. 2021
Efficacy and Safety of Tocilizumab for Polyarticular-Course Juvenile Idiopathic Arthritis in the Open-Label 2-Year Extension of a Phase 3 Trial.
Brunner HI; (...); Paediatric Rheumatology International Trials Organisation (PRINTO), the Pediatri
Article. 10.1002/art.41528. 2020
EFFICACY OF CANAKINUMAB, ON A REDUCED DOSE OR A PROLONGED DOSE INTERVAL WITHOUT CONCOMITANT CORTICOSTEROIDS AND METHOTREXATE, IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
Quartier, P; (...); Martini, A
Meeting Abstract. 10.1136/annrheumdis-2019-eular.1558. 2019
Epidemiological and clinical features of Kawasaki disease in Spain over 5 years and risk factors for aneurysm development. (2011-2016): KAWA-RACE study group
Fernandez-Cooke, E; (...); KAWA-RACE Study Grp
Article. 10.1371/journal.pone.0215665. 2019
EVALUATING REAL LIFE CRITERIA THAT COULD DRIVE PRICING & REIMBURSEMENT (P&R) APPROVAL OF ORPHAN DRUGS (ODS) IN SPAIN
Badia, F. J.; (...); Shepherd, J.
Meeting Abstract. 2019
EXTENDED MULTICRITERIA DECISION ANALYSIS IN DIABETIC MACULAR EDEMA. MULTIDEX-EMD EXTENSION STUDY
F, de Andres-Nogales; (...); Martinez, M.
Meeting Abstract. 2019
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
Genotype FBN1/Phenotype relationship in a cohort of patients with Marfan syndrome.
Hernándiz A; (...); Sepúlveda P
Article. 10.1111/cge.13879. 2020
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
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
Impact of combinations of single-nucleotide polymorphisms of anthracycline transporter genes upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia.
Megías-Vericat JE; (...); Montesinos P
Article. 10.1080/10428194.2020.1839650. 2020
Impact of the therapeutic positioning report in the P&R process in Spain: analysis of orphan drugs approved by the European Commission and reimbursed in Spain from 2003 to 2019
Badia X; (...); Hernández C
Article. 10.1186/s13023-020-01507-4. 2020
Impact of voriconazole plasma concentrations on treatment response in critically ill patients
Ruiz, J; (...); Ramirez, P
Article. 10.1111/jcpt.12817. 2019
Implementation and results of a risk-sharing scheme for enzyme replacement therapy in lysosomal storage diseases
Edo-Solsona, MD, Vitoria-Minana, I, Poveda-Andres, JL
Article. 10.7399/fh.11262. 2020
Improvement in Patient-Reported Outcomes in Patients Aged 2-5 Years with Polyarticular-Course JIA Treated with Subcutaneous Abatacept: 2-Year Results from a Phase III International Study
Brunner, Hermine; (...); Ruperto, Nicolino
Meeting Abstract. 2019
INFLUENCE OF ANTI-TUMORNECROSIS FACTOR (TNF) DRUG IMMUNOGENICITY ON THE TREATMENT EFFECTIVENESS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) USING SERUM CALPROTECTIN AS A DISEASE ACTIVITY MARKER. MULTICENTER STUDY. ITACA STUDY
Calvo, I; (...); Anton, J
Meeting Abstract. 10.1136/annrheumdis-2019-eular.7963. 2019
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
Intraperitoneal vancomycin in neonates during peritoneal dialysis: A case report
Company-Albir, MJ; (...); Poveda, JL
Article. 10.1111/jcpt.12842. 2019
Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial.
Mallalieu NL; (...); Wouters C
Article. 10.1186/s12969-019-0364-z. 2019
Intravitreal melphalan therapy for vitreous seeds in retinoblastoma: Implementation and outcomes of a new chemotherapy protocol.
Solana-Altabella A; (...); Poveda JL
Article. 10.1177/1078155220904410. 2020
Involvement of interleukin 6 in SARS-CoV-2 infection: siltuximab as a therapeutic option against COVID-19
Palanques-Pastor, T, Lopez-Briz, E, Andres, JLP
Article. 10.1136/ejhpharm-2020-002322. 2020
LONG TERM IMMUNITY IN A PAEDIATRIC COHORT OF PATIENTS WITH RHEUMATIC DISEASES FROM A TERTIARY HOSPITAL IN SPAIN
Silveira, LF; (...); Calvo, Inmaculada
Meeting Abstract. 10.1136/annrheumdis-2019-eular.6378. 2019
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
Lupus neonatal.
Torres-Navarro I, López-Montesinos B, Évole-Buselli M
Editorial Material. 10.1016/j.anpedi.2020.07.014. 2021
Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.
Brunner HI; (...); Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology
Article. 10.1186/s12969-020-0410-x. 2020
Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.
Megías-Vericat JE; (...); Poveda-Andrés JL
Article. 2021
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
Metyrapone as treatment in the neonatal McCune-Albright syndrome
de Mingo, Carmen; (...); Garcia-Robles, Ana
Article. 10.1515/jpem-2020-0036. 2020
MEVALONATE KINASE DEFICIENCY AT TREATMENT WITH CANAKINUMAB: RARE BELATED CUTANEOUS FEATURE
Sobrin, RD; (...); Calvo, I.
Meeting Abstract. 10.1136/annrheumdis-2020-eular.1357. 2020
Monitoring coagulation factors during surgery. A systematic review
Eduardo Megias-Vericat, Juan; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11766. 2021
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
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
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
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol
Garcia-Robles, Ana; (...); Carrascosa, MA
Article. 10.3389/fped.2020.00372. 2020
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
Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy
Margusino-Framiñán L; (...); Morillo-Verdugo R
Article. 10.7399/fh.11498. 2020
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
PK-GUIDED SWITCH BETWEEN STANDARD HALF-LIFE AND EXTENDED HALF-LIFE FACTOR VIII PRODUCTS
Vericat, JEM; (...); Iorio, A
Meeting Abstract. 2020
PRELIMINAR STUDY OF THERAPY ADHERENCE CONTROLLED BY PRESCRIPTION OF MEDICATION AND SELF-PERCEPTION ADHERENCE OF INFLAMMATORY CHRONIC DISEASE PATIENTS
Garcia, EG; (...); Ivorra, JAR
Meeting Abstract. 10.1136/annrheumdis-2019-eular.5937. 2019
Preparación y administración de perfusiones de insulina en neonatología: Encuesta nacional.
García-Robles A; (...); Aguar-Carrascosa M
Letter. 10.1016/j.anpedi.2020.06.008. 2021
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
Proactive therapeutic drug monitoring and pharmacogenetic analysis in inflammatory bowel disease: A systematic review
Ballesta-Lopez, Octavio; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11780. 2021
Rapid and Sustained Long-Term Efficacy and Safety of Canakinumab in Patients With Cryopyrin-Associated Periodic Syndrome Ages Five Years and Younger.
Brogan PA; (...); Laxer RM
Article. 10.1002/art.41004. 2019
Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial
Brunner, HI; (...); Pediat Rheumatology Collab
Article. 10.1136/annrheumdis-2020-217101. 2020
SARILUMAB, A HUMAN MONOCLONAL ANTIBODY TO THE INTERLEUKIN-6 (IL-6) RECEPTOR, IN POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS (PCJIA): A 12-WEEK MULTINATIONAL OPEN-LABEL DOSE-FINDING STUDY
De Benedetti, F; (...); DRI13925 Investigators
Meeting Abstract. 10.1136/annrheumdis-2019-eular.4651. 2019
Sarilumab, a Human Monoclonal Antibody to the Interleukin-6 Receptor, in Polyarticular-course Juvenile Idiopathic Arthritis: A 12-week, Multinational, Open-label, Dose-finding Study
De Benedetti, Fabrizio; (...); Baret-Cormel, Lydie
Meeting Abstract. 2019
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
SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11565. 2020
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
Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule.
Marques MR; (...); Mangas-Sanjuan V
Article. 10.1111/apa.14944. 2020
Towards a symbiotic relationship between big data, artificial intelligence, and hospital pharmacy
Del Rio-Bermudez, C; (...); Poveda, JL
Editorial Material. 10.1186/s40545-020-00276-6. 2020
Undetectable levels of adalimumab in clinical practice: Should we say goodbye to the drug?
Bejar, S; (...); Mateu, PN
Meeting Abstract. 2020
USE OF CAPLACIZUMAB IN THE ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA
Dominguez Hernandez, L.; (...); Gomez Segui, I
Meeting Abstract. 2019
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