ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, COMPUESTO DE TRES PARTES PARA INVESTIGAR LA EFICACIA Y SEGURIDAD DEL TRATAMIENTO CON SECUKINUMAB EN SUBTIPOS DE ARTRITIS IDIOPÁTICA JUVENIL DE LA ARTRITIS PSORIÁSICA Y ARTRITIS RELACIONADA CON ENTESITIS.

Datos básicos

Protocolo:
CAIN457F2304
EUDRACT:
2016-003761-26
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2017
Año de finalización:
2020
ENSAYO CLÍNICO INTERNACIONAL

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

NOVARTIS FARMACEUTICA, S.A.

Resultados del Ensayo Clínico


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

  • Open Access.

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

  • Open Access.

Anti-Interleukin-6 Receptor Tocilizumab for Severe Juvenile Idiopathic Arthritis-Associated Uveitis Refractory to Anti-Tumor Necrosis Factor Therapy A Multicenter Study of Twenty-Five Patients

Calvo-Rio, V; (...); Blanco, R

Article. 10.1002/art.39940. 2017

  • Open Access.

Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes

De Benedetti, F; (...); Junge, G

Article. 10.1056/NEJMoa1706314. 2018

  • Open Access.

CANAKINUMAB TREATMENT IN PATIENTS WITH COLCHICINE-RESISTANT FMF (CRFMF), HIDS/MKD AND TRAPS: EFFICACY IN THE 16 WEEKS RANDOMISED CONTROLLED PHASE AND MAINTENANCE OF DISEASE CONTROL AND SAFETY AT WEEK 40

De Benedetti, F; (...); Junge, G

Meeting Abstract. 10.1136/annrheumdis-2017-eular.2194. 2017


Canakinumab, on a Reduced Dose or a Prolonged Dose Interval without Concomitant Corticosteroids and Methotrexate, Maintains Efficacy in Systemic Juvenile Idiopathic Arthritis Patients in Clinical Remission

Quartier, P; (...); Martini, A

Meeting Abstract. 2018


CASE-REVIEW ON FAMILIAL MEDITERRANEAN FEVER IN A SPECIALIZED CENTRE

Sobrin, RD; (...); Calvo, I.

Meeting Abstract. 10.1136/annrheumdis-2020-eular.1355. 2020


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


COMPARATIVE STUDY OF THE TREATMENT OF REFRACTORY CYSTOID MACULAR OEDEMA TO CONVENTIONAL IMMUNOSUPPRESSIVE THERAPY: TOCILIZUMAB VS ANTI-TNF. MULTICENTER STUDY OF 59 PATIENTS

Martin-Varillas, JL; (...); Blanco, R

Meeting Abstract. 10.1136/annrheumdis-2018-eular.3999. 2018

  • Open Access.

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

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

Article. 10.1186/s13023-024-03248-0. 2024

  • Open Access.

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


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

  • Open Access.

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

  • Open Access.

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


Efficacy and Safety of Canakinumab in Patients with Periodic Fever Syndromes (Colchicine-Resistant FMF, HIDS/MKD and TRAPS): Results from a Phase 3, Pivotal, Umbrella Trial

De Benedetti, F; (...); Junge, G

Meeting Abstract. 2017


Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus

Brunner, HI; (...); Ruperto, N

Meeting Abstract. 2018


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Evaluation of a Dosing Regimen for Tocilizumab in Patients Younger Than Two Years of Age with Systemic Juvenile Idiopathic Arthritis

Mallalieu, NL; (...); Wouters, C

Meeting Abstract. 2017


EVALUATION OF A DOSING REGIMEN FOR TOCILIZUMAB IN PATIENTS YOUNGER THAN TWO YEARS OF AGE WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Mallalieu, NL; (...); Wouters, C

Meeting Abstract. 10.1136/annrheumdis-2017-eular.2386. 2017


Evaluation of a Dosing Regimen for Tocilizumab in Patients Younger Than Two Years of Age With Systemic Juvenile Idiopathic Arthritis

Mallalieu, NL; (...); Wouters, C

Meeting Abstract. 2017


Expert panel consensus recommendations for diagnosis and treatment of secondary osteoporosis in children.

Galindo-Zavala R; (...); Graña-Gil J

Article. 10.1186/s12969-020-0411-9. 2020

  • Open Access.

Genotype FBN1/Phenotype relationship in a cohort of patients with Marfan syndrome.

Hernándiz A; (...); Sepúlveda P

Article. 10.1111/cge.13879. 2020


Golimumab Versus Tocilizumab in Uveitis Related to Refractory Juvenile Idiopathic Arthritis. National Multicenter Study of 33 Patients

Dominguez-Casas, LC; (...); Blanco, R

Meeting Abstract. 2017


Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial

Bharucha, KN; (...); Pediat Rheumatology Collaborative

Article. 10.3899/jrheum.170326. 2018

  • Open Access.

High-throughput sequencing for the molecular diagnosis of Usher syndrome reveals 42 novel mutations and consolidates CEP250 as Usher-like disease causative

Fuster-Garcia, C; (...); Millan, JM

Article. 10.1038/s41598-018-35085-0. 2018

  • Open Access.

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


IDENTIFICATION OF OPTIMAL SUBCUTANEOUS DOSES OF TOCILIZUMAB IN CHILDREN WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Brunner, H; (...); PRCSG Investigator

Meeting Abstract. 10.1136/annrheumdis-2018-eular.2624. 2018

  • Open Access.

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

  • Open Access.

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


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

  • Open Access.

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 Active Hyperimmunoglobulinemia D with Periodic Fever Syndrome

Ignacio Arostegui, Juan; (...); Yague, Jordi

Meeting Abstract. 10.1542/peds.141.1_MeetingAbstract.270. 2018


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Lupus neonatal.

Torres-Navarro I, López-Montesinos B, Évole-Buselli M

Editorial Material. 10.1016/j.anpedi.2020.07.014. 2021

  • Open Access.

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

  • Open Access.

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.

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

  • Open Access.

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


Open-Label, Phase II Study to Assess the Efficacy and Safety of Canakinumab Treatment in Active Hyperimmunoglobulinemia D With Periodic Fever Syndrome

Arostegui, JI; (...); Yague, J

Article. 10.1002/art.40146. 2017

  • Open Access.

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


Prevention and early diagnosis of childhood osteoporosis: are we doing the right thing?

Mir-Perello, C; (...); Osteogenesis Imperfecta Sociedad E

Article. 10.4321/S1889-836X2018000100005. 2018

  • Open Access.

Purtscher-like retinopathy associated with dermatomyositis and hemophagocytic lymphohistiocytosis.

Barreiro-González A; (...); Azorín Villena I

Article. 10.1016/j.oftal.2017.03.009. 2018


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

  • Open Access.

Rapid Improvement with Tocilizumab in Refractory and Severe Uveitic Cystoid Macular Edema

Vegas-Revenga, N; (...); Blanco, R

Meeting Abstract. 2017


Rapidly progressive violaceous and necrotic plates in a 5-year-old child

Sahuquillo-Torralba A; (...); Evole-Buselli, M

Editorial Material. 10.1016/j.medcli.2017.03.033. 2018


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

  • Open Access.

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

  • Open Access.

Refractory and Severe Uveitic Cystoid Macular Edema Improves with Tocilizumab in Different Immune Mediated Diseases

Vegas-Revenga, N; (...); Blanco, R

Meeting Abstract. 2018


REFRACTORY AND SEVERE UVEITIC CYSTOID MACULAR OEDEMA IMPROVES WITH TOCILIZUMAB IN DIFFERENT IMMUNE-MEDIATED INFLAMMATORY DISEASES

Vegas-Revenga, N; (...); Blanco, R

Meeting Abstract. 10.1136/annrheumdis-2018-eular.4024. 2018

  • Open Access.

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

  • Open Access.

SAFETY OF TOCILIZUMAB IN PATIENTS AGED < 2 YEARS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS TREATED FOR ONE YEAR

Wimalasundera, S; (...); Wouters, C

Meeting Abstract. 10.1136/annrheumdis-2018-eular.2628. 2018

  • Open Access.

Safety of Tocilizumab in Patients Aged < 2 Years with Active Systemic Juvenile Idiopathic Arthritis Treated for One Year

Wimalasundera, S; (...); Wouters, C

Meeting Abstract. 2018


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

  • Open Access.

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 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

  • Open Access.

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


Short and Long-Term Follow-up of Tocilizumab for Severe Juvenile Idiopathic Arthritis-Associated Uveitis

Vegas-Revenga, N; (...); Blanco, R

Meeting Abstract. 2017


Subcutaneous Abatacept in Patients Aged 2-17 Years with Polyarticular Juvenile Idiopathic Arthritis and Inadequate Response to Biologic or Non-Biologic Disease-Modifying Antirheumatic Drugs: Pharmacokinetics, Effectiveness, Safety and Immunogenicity over 2 Years

Brunner, HI; (...); Martini, A

Meeting Abstract. 2017


SUBCUTANEOUS ABATACEPT IN PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS AND INADEQUATE RESPONSE TO BIOLOGIC OR NON-BIOLOGIC DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS: PHARMACOKINETICS, EFFICACY AND SAFETY

Ruperto, N; (...); PRINTO PRCSG

Meeting Abstract. 2017


Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Results From a Phase III Open-Label Study

Brunner, HI; (...); Pediat Rheumatology Collaborative

Article. 10.1002/art.40466. 2018

  • Open Access.

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

  • Open Access.

The Castilian Spanish version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR)

de Inocencio, J; (...); Paediat Rheumatology Int Trials

Article. 10.1007/s00296-018-3976-6. 2018

  • Open Access.

Treatment of Refractory Cystoid Macular Edema to Conventional Immunosuppressive Therapy: Tocilizumab Vs Anti-TNF-Alpha. Multicenter Study of 59 Patients

Martin-Varillas, JL; (...); Blanco, R

Meeting Abstract. 2018


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

  • Open Access.

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

  • Open Access.

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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