Estudio de fase 3 aleatorizado, controlado con placebo y doble ciego de 24 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de rocatinlimab (AMG 451) en monoterapia en sujetos adultos con dermatitis atópica (DA) de moderada a grave (ROCKET-Ignite).

Datos básicos

Protocolo:
20210142
EUDRACT:
2022-000711-31
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2023
Año de finalización:
2024
ENSAYO CLÍNICO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

AMGEN SA

Resultados del Ensayo Clínico


"Phytophotodermatitis as a clinical problem and as a therapeutic option: case report and review of the literature".

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1016/j.pdpdt.2023.103304. 2023


[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

  • Open Access.

[[Translated article]]Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

Sanchez-Diaz, M; (...); Carrascosa-Carrillo, J M

Article. 10.1016/j.ad.2024.01.019. 2024

  • Open Access.

[Translated article] BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.

Munera-Campos M; (...); Carrascosa JM

Article. 10.1016/j.ad.2023.05.010. 2023

  • 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

  • Open Access.

Acute performance of stylet driven leads for left bundle branch area pacing: A comparison with lumenless leads

Cano, Oscar; (...); Batul, Syeda Atiqa

Article. 10.1016/j.hroo.2023.11.014. 2023

  • Open Access.

Altered MicroRNA Maturation in Ischemic Hearts: Implication of Hypoxia on XPO5 and DICER1 Dysregulation and RedoximiR State.

Perez-Carrillo, Lorena; (...); Rosello-Lleti, Esther

Article. 10.3390/antiox12071337. 2023

  • Open Access.

Analysis of Heart Transplant Survival According to Difference in Age Between Donor and Recipient.

Lopez-Vilella, Raquel; (...); Almenar-Bonet, Luis

Article. 10.1016/j.transproceed.2022.10.014. 2022


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

  • Open Access.

BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.

Munera-Campos M; (...); Carrascosa JM

Article. 10.1016/j.ad.2023.03.001. 2023

  • Open Access.

CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)

Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda

Correction. 10.1016/j.rec.2023.03.018. 2023


Casal necklace.

Mansilla-Polo, Miguel, Martin-Torregrosa, Daniel, Botella-Estrada, Rafael

Article. 10.1016/j.medcli.2023.03.035. 2023


Clinical phenotypes according to diuretic combination in acute heart failure.

Lopez-Vilella, Raquel; (...); Bonet, Luis Almenar

Article. 10.1016/j.hjc.2023.03.009. 2023

  • Open Access.

Clinical profiling of patients admitted with acute heart failure: a comprehensive survival analysis.

Lopez-Vilella, Raquel; (...); Almenar Bonet, Luis

Article. 10.3389/fcvm.2024.1381514. 2024

  • Open Access.

Clinicopathological characteristics of cutaneous and mucocutaneous leishmaniasis in patients treated with TNF-alpha inhibitors.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007. 2023

  • Open Access.

Combining Serum miR-144-3p and miR-652-3p as Potential Biomarkers for the Early Diagnosis and Stratification of Acute Cellular Rejection in Heart Transplantation Patients.

Pérez-Carrillo L; (...); Roselló-Lletí E

Article. 10.1097/TP.0000000000004622. 2023

  • Open Access.

Conduction System Pacing for Cardiac Resynchronization Therapy

Cano, Oscar; (...); Martinez-Dolz, Luis

Review. 10.3390/jcdd10110448. 2023

  • Open Access.

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

  • Open Access.

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


Contact dermatitis by face mask.

Mansilla-Polo M, Navarro-Mira MÁ, Botella-Estrada R

Article. 10.1016/j.medcli.2023.01.004. 2023


Cutaneous larva migrans.

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1016/j.medcli.2023.03.037. 2023

  • Open Access.

Cutaneous sarcoidosis after platelet-rich plasma injections and permanent eyebrow make-up.

Torregrosa DM; (...); Estrada RB

Case Reports. 10.1016/j.ad.2023.06.023. 2024

  • Open Access.

Characterizing chronic hepatitis delta in Spain and the gaps in its management

Rodriguez-Tajes, Sergio; (...); Lens, Sabela

Meeting Abstract. 2023


Dermatologic consultations for patients hospitalized in non-dermatologic wards: results of a 384-patient cross-sectional study from a tertiary referral hospital.

Mansilla-Polo, M; (...); Botella-Estrada, R

Case Reports. 10.1016/j.ad.2023.11.021. 2023


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

  • Open Access.

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

  • Open Access.

Development and validation of a model to predict complex Mohs Micrographic Surgery in clinical practice: REGESMOSH scale.

Montero-Vilchez, Trinidad R.; (...); Sanmartin-Jimenez, Onofre

Article. 10.1111/jdv.19056. 2023

  • Open Access.

Does fractional flow reserve impact on clinical outcomes by reducing number of stents and contrast media? Findings from a systematic review (N = 56,185) and meta-analysis.

Teira Calderón A; (...); Garcia-Garcia HM

Letter. 10.1016/j.carrev.2023.12.010. 2024

  • Open Access.

Dose reduction is a feasible strategy in patients with plaque psoriasis who achieve sustained response with secukinumab: a retrospective, multicenter cohort study in daily practice setting

Daudén E; (...); Llamas-Velasco M

Article. 10.1111/ijd.16915. 2024

  • Open Access.

Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: a Spanish multicenter cohort study

Lasheras-Pérez MA; (...); Rodríguez-Serna M

Article. 10.1111/ijd.17030. 2024

  • Open Access.

Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study.

Phan, Duc Binh; (...); Yiu ZZN

Article. 10.1136/bmjopen-2023-075197. 2023

  • Open Access.

Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).

Rodriguez, C Couselo; (...); Florez, A.

Article. 10.1016/j.ad.2023.07.014. 2023

  • Open Access.

Dupilumab for atopic dermatitis during pregnancy and breastfeeding: Clinical experience in 13 patients.

Escolà H; (...); Curto-Barredo L

Letter. 10.1111/jdv.19165. 2023


Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.

Sahuquillo-Torralba, A; (...); Botella-Estrada, R

Article. 10.1111/ajd.14130. 2023


Effectiveness of Secukinumab for the treatment of erythrodermic psoriasis. Multicenter study in daily practice.

Reymundo, A; (...); Dauden, E

Letter. 10.1111/jdv.19371. 2023


Effectiveness, safety and satisfaction of 1% tirbanibulin ointment in the treatment of actinic keratoses: A prospective study in real clinical practice.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ajd.14151. 2023


Fatal outcome in classic Kaposi's sarcoma.

Mansilla-Polo M, Botella-Estrada R

Article. 10.1016/j.ad.2023.03.013. 2024

  • Open Access.

Four-year epidemiological surveillance of the Spanish Registry of Contact Dermatitis and Cutaneous Allergy (REIDAC): Current situation and trends.

Romero FT; (...); de Frutos JO

Article. 10.1016/j.ad.2023.10.039. 2024

  • Open Access.

Hemihypoatrophy as an extraordinary manifestation of linear morphoea.

Mansilla-Polo, Miguel, Navarro-Mira, Miguel A., Botella-Estrada, Rafael

Article. 10.1093/rap/rkac104. 2022

  • Open Access.

How can artificial intelligence optimize value-based contracting?

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

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

  • Open Access.

Identification of c.104T>G, p.Met35Arg (NM_00314.8) variant in heterozygosity in exon 2 of the PTEN gene as the Causative Factor for Cowden Syndrome: A Medical Case Study.

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1093/ced/llad344. 2023


Impact of Advanced Age on the Incidence of Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes Mellitus and Stable Coronary Artery Disease in a Real-World Setting in Spain.

González-Juanatey C; (...); Savana Research Group

Article. 10.3390/jcm12165218. 2023

  • Open Access.

Innovations of Spanish code of medical deontology

Lasheras-Pérez MA; (...); Unamuno Bustos B

Letter. 10.1016/j.semerg.2023.102137. 2024

  • Open Access.

Is the Benefit of Treating Iron Deficiency Greater in Acute Heart Failure with Renal Dysfunction?

Lopez-Vilella, Raquel; (...); Almenar Bonet L

Article. 10.3390/life13040915. 2023

  • Open Access.

Klinisch-pathologische Eigenschaften kutaner und mukokutaner Leishmaniose bei mit TNF-a-Inhibitoren behandelten Patienten.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007_g. 2023

  • Open Access.

Left bundle branch pacing versus left ventricular septal pacing as a primary procedural endpoint during left bundle branch area pacing: Evaluation of two different implant strategies.

Cano, Oscar; (...); Martinez-Dolz, Luis

Article. 10.1111/jce.16128. 2023


Long-term outcomes of extended DAPT in a real-life cohort of consecutive STEMI patients.

Tizón-Marcos H; (...); Marrugat J

Article. 10.1016/j.rec.2022.12.003. 2023

  • Open Access.

Melanoma and LEOPARD Syndrome: Understanding the Role of PTPN11 Mutations in Melanomagenesis.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.2340/actadv.v104.14720. 2024

  • Open Access.

Mortality after the first hospital admission for acute heart failure de novo vs. acutely decompensated heart failure with reduced ejection fraction

Lopez Vilella, R. Raquel; (...); Almenar Bonet, L.

Meeting Abstract. 2023


Mortality After the First Hospital Admission for Acute Heart Failure, De Novo Versus Acutely Decompensated Heart Failure With Reduced Ejection Fraction.

Lopez-Vilella, Raquel; (...); Almenar Bonet, Luis

Article. 10.1016/j.amjcard.2023.03.008. 2023

  • Open Access.

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo M, Escutia-Muñoz B, Botella-Estrada R

Article. 10.1016/j.ad.2023.08.001. 2023

  • Open Access.

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo, M., Escutia-Munoz, B., Botella-Estrada, R.

Article. 10.1016/j.ad.2023.05.015. 2023

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

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

Review. 10.3390/biology12091159. 2023

  • Open Access.

Papulonecrotic tuberculides as a key to the diagnosis of tuberculosis: a case report.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ijd.16940. 2024


Patch Testing in Patients With Severe Atopic Dermatitis Treated With Dupilumab: A Multicentric Approach in Spain.

Docampo-Simon, Alexandre; (...); Silvestre, Juan F.

Article. 10.1089/derm.2022.0023. 2023


Pharmacogenetic biomarkers for secukinumab response in psoriasis patients in real-life clinical practice.

Munoz-Aceituno, E.; (...); de la Fuente, H.

Article. 10.1111/jdv.19782. 2023


Plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty. The PLAMI study design

Romero, Jose Antonio Sorolla; (...); Sanchez, Jorge Sanz

Article. 10.24875/RECIC.M23000438. 2024

  • Open Access.

Podoconiosis.

Mansilla-Polo, Miguel, Lopez-Leon, Paula Teresa, Botella-Estrada, Rafael

Article. 10.1001/jamadermatol.2023.4143. 2023


Porto sinusoidal vascular liver disorder: natural history and long-term outcome

Magaz, Marta; (...); Garcia Pagan, Juan Carlos

Meeting Abstract. 2023


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.

Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023


Prognostic factors for satellitosis or in-transit metastasis in cutaneous squamous cell carcinoma: A multicentric cohort study.

Marti-Marti I; (...); Toll A

Article. 10.1016/j.jaad.2023.02.048. 2023


Raccoon eyes as a diagnostic key for suspected amyloidosis

Mansilla-Polo, Miguel, Botella-Estrada, Rafael

Editorial Material. 10.1093/rap/rkad105. 2023

  • Open Access.

Reactive arthritis.

Mansilla-Polo M; (...); Botella-Estrada R

Article. 10.1016/j.medcli.2023.08.017. 2023


Real-life effectiveness of voxilaprevir/sofosbuvir/velpatasvir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir

Ruiz-Cobo, Juan Carlos; (...); Lens, Sabela

Meeting Abstract. 2023


Recalcitrant Hailey-Hailey Disease With Satisfactory Response to Apremilast.

Mansilla-Polo, M; (...); Botella-Estrada, R

Case Reports. 10.1016/j.ad.2023.05.022. 2023


Refractory cutaneous lupus erythematosus successfully treated with anifrolumab: a case series.

Martin-Torregrosa, Daniel; (...); Torres-Navarro, Ignacio

Letter. 10.1111/ijd.17022. 2024


Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

Sanchez-Diaz, M.; (...); Carrascosa-Carrillo, J. M.

Article. 10.1016/j.ad.2023.10.016. 2023

  • Open Access.

Rivaroxaban improves survival and decompensation in cirrhotic patients with moderate liver dysfunction. Double-blind, placebocontrolled trial

Puente Sanchez, Angela; (...); Garcia Pagan, Juan Carlos

Meeting Abstract. 2023


Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

Lluch-Galcera, Juan Jose; (...); Garcia-Doval, Ignacio

Article. 10.1093/bjd/ljad382. 2023


Scalp Melanoma: A High-Risk Subset of Cutaneous Head and Neck Melanomas with Distinctive Clinicopathological Features.

Palacios-Diaz RD; (...); Botella-Estrada R

Article. 10.3390/jcm12247643. 2023

  • Open Access.

Single Digital Metastasis of Rectal Adenocarcinoma

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Letter. 10.1097/DAD.0000000000002529. 2023

  • Open Access.

Skin lesions in a lung transplant recipient.

Mansilla-Polo M; (...); Botella-Estrada R

Case Reports. 10.1016/j.eimce.2023.09.005. 2024

  • Open Access.

Sodium metabisulfite a current low relevant allergen in Spain.

Sanz-Sanchez, Tatiana; (...); Borrego, Leopoldo

Letter. 10.1111/jdv.19702. 2023


Successful treatment of field of cancerization in the dorsum of the hands with 1% tirbanibulin ointment.

Abril-Perez, Carlos; (...); Botella-Estrada, Rafael

Article. 10.1093/ced/llad171. 2023


Survey to evaluate the implementation of the recommendations on the comprehensive diagnosis of viral hepatitis in a single extraction: where are we?

Cabezas, Joaquin; (...); Crespo, Javier

Meeting Abstract. 2023


SURVEY TO EVALUATE THE IMPLEMENTATION OF THE RECOMMENDATIONS ON THE COMPREHENSIVE DIAGNOSIS OF VIRAL HEPATITIS IN A SINGLE EXTRACTION: WHERE ARE WE?

Cabezas, Joaquin; (...); Crespo Garcia, Javier

Meeting Abstract. 2023


Switching from dupilumab to tralokinumab in patients with atopic dermatitis due to inefficacy or side effects.

Lasheras-Pérez MA; (...); Rodriguez-Serna M

Article. 10.1111/ijd.16926. 2024


Tattoo-Associated Common Wart.

Mansilla-Polo, M, Llavador-Ros, M, Botella-Estrada, R

Article. 10.1016/j.ad.2023.04.037. 2023


Therapeutic approach in heart failure with poor diuretic response. Peripheral ultrafiltration vs. conventional treatment

Lopez-Vilella, R.; (...); Almenar Bonet, L.

Meeting Abstract. 2023


Therapeutic approach in heart failure with poor diuretic response: peripheral ultrafiltration vs. conventional treatment.

López-Vilella R; (...); Almenar Bonet L

Article. 10.1002/ehf2.14386. 2023

  • Open Access.

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


Why Iron Deficiency in Acute Heart Failure Should Be Treated: A Real-World Clinical Practice Study.

Lopez-Vilella, Raquel; (...); Almenar Bonet, Luis

Article. 10.3390/life12111828. 2022

  • Open Access.

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