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
ENSAYO CLÍNICO INTERNACIONAL

Documentos

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Participantes

Grupos

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


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

  • Open Access.

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

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


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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