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- ENSAYO CLINICO FASE III, DE GRUPOS PARALELOS, RANDOMIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICENTRICO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LA ADMINISTRACION DE TOCILIZUMAB EN PACIENTES DIAGNOSTICADOS DE ORBITOPATÍA TIROIDEA (OT) MODERADA A SE VERA O QUE AMENAZA LA VISTA, QUE NO HAN RESPONDIDO ADECUADAMENTE AL TRATAMIENTO CON PULSOS DE CORTICOIDES.
ENSAYO CLINICO FASE III, DE GRUPOS PARALELOS, RANDOMIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICENTRICO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LA ADMINISTRACION DE TOCILIZUMAB EN PACIENTES DIAGNOSTICADOS DE ORBITOPATÍA TIROIDEA (OT) MODERADA A SE VERA O QUE AMENAZA LA VISTA, QUE NO HAN RESPONDIDO ADECUADAMENTE AL TRATAMIENTO CON PULSOS DE CORTICOIDES.
Datos básicos
- Protocolo:
- GRC-TCL-2010-01
- EUDRACT:
- 2010-023841-31
- NCT:
- Centro:
- Año de incio:
- 2013
- Año de finalización:
- 2015
Documentos
- No hay documentos
Participantes
-
Enrique España Gregori
Investigador Principal
Financiadores - Promotores
Resultados del Ensayo Clínico
"Venous cavernous malformation in the infraorbital canal with unusual presentation".
Solaz-Ruiz, M G; (...); Espana-Gregori, E
Article. 10.1016/j.oftale.2025.01.009. 2025
Absceso orbitario tras anestesia peribulbar en mucocele frontoetmoidal.
Pardo-López D; (...); Diaz-Llopis M
Abstract of Published Item. 10.1016/j.oftal.2013.02.009. 2014
Acute calcareous corneal degeneration in a patient with chronic graft-versus-host disease.
Ruiz, Marta Gema Solaz; (...); Gregori, Enrique Espana
Review. 10.22336/rjo.2024.10. 2024
Angiofibroma nasofaringeo juvenil con extension orbitaria.
Hervas Ontiveros A; (...); Simal Julian JA
Article. 10.1016/j.oftal.2014.02.010. 2015
Anterior Segment Biometry and Their Correlation with Corneal Biomechanics in Caucasian Children
Bueno-Gimeno, I; (...); Espana-Gregori, E
Article. 10.1080/02713683.2018.1539181. 2019
Antireconverin antibodies in ocular chronic graft versus host disease: A new cause of nonparaneoplasic autoimmune retinopathy
Aguilar Gonzalez, Marina; (...); Espana Gregori, Enrique
Article. 10.1177/11206721221123779. 2022
Assessment of the quality of sample labelling for clinical research.
Pérez-Huertas P; (...); Poveda-Andrés JL
Article. 10.7399/fh.2016.40.2.9753. 2016
Association between Tomographic Characteristics of Pterygium and Preoperative Anterior and Posterior Topography Measured by Anterior Segment Optical Coherence Tomography
Aguilar-Gonzalez, Marina; (...); Peris-Martinez, Cristina
Article. 10.3390/life14101245. 2024
AUTOMATED CAPILLARY DETECTION AND IMAGE ANALYSIS SOFTWARE IN CAPILLAROSCOPY: CAPILLARY.IO
Tello, BG; (...); Fanlo, P
Meeting Abstract. 10.1136/annrheumdis-2021-eular.4022. 2021
AUTOMATED DETECTION OF SCLERODERMIFORM PATTERNS USING CAPILLARY.IO
Ramos, E; (...); Fanlo, P
Meeting Abstract. 10.1136/annrheumdis-2021-eular.4112. 2021
Calidad y Legibilidad de la Hoja de Informacion al Paciente en Estudios con Analisis Farmacogenetico.
Ruiz Ramos J; (...); Poveda Andrés JL
Article. 2015
Capi-score: a quantitative algorithm for identifying disease patterns in nailfold videocapillaroscopy.
Gracia Tello BC; (...); Ramos Ibáñez E
Article. 10.1093/rheumatology/keae197. 2024
Clinical and epidemiological differences between men and women with systemic sclerosis: a study in a Spanish systemic sclerosis cohort and literature review
Freire, M; (...); RESCLE Investigators, Autoimmune D
Review. 2017
Corneal Biomechanical Parameters With Corneoscleral Contact Lenses in Post-Laser In Situ Keratomileusis Eyes
Montalt, JC; (...); Peris-Martinez, C
Article. 10.1097/ICL.0000000000000420. 2018
Corneal Biomechanics, Retinal Nerve Fiber Layer, and Optic Disc in Children
Bueno-Gimeno, I; (...); Espana-Gregori, E
Article. 10.1097/OPX.0000000000000406. 2014
Corneo-scleral contact lens in a piggyback system for keratoconus: A case report
Porcar, Esteban; (...); Peris-Martinez, Cristina
Article. 10.1016/j.clae.2016.12.007. 2017
Corneoscleral contact lenses fitting on irregular corneas after laser-assisted in situ keratomileusis
Montalt, JC; (...); Peris-Martinez, C
Article. 10.5935/0004-2749.20180061. 2018
Corneoscleral contact lenses for visual rehabilitation after keratoplasty surgery.
Montalt JC; (...); Peris-Martínez C
Article. 10.1016/j.clae.2020.04.009. 2020
Corneo-scleral contact lenses in an uncommon case of keratoconus with high hyperopia and astigmatism
Porcar, E; (...); Peris-Martinez, C
Article. 10.1016/j.clae.2017.07.004. 2017
Corrigendum to 'Spanish scleroderma risk score (RESCLESCORE) to predict 15-year all-cause mortality in scleroderma patients at the time of diagnosis based on the RESCLE cohort: Derivation and internal validation' [AUTREV 19-5 (2020) 102507].
Rubio-Rivas M; (...); Simeón Aznar CP
Article. 10.1016/j.autrev.2021.102793. 2021
CHARACTERISTICS ASSOCIATED TO SCLERODERMAL RENAL CRISIS, AND INCIDENCE VARIATION OVER TIME IN THE RESCLE REGISTRY
Salas, XP; (...); Simeon-Aznar, CP
Meeting Abstract. 10.1136/annrheumdis-2019-eular.3406. 2019
CHARACTERIZATION OF SCLERODERMA PATIENTS ACCORDING TO RO52 AND KU ANTIBODIES
Castro, JC; (...); Rescle Investigators
Meeting Abstract. 10.1136/annrheumdis-2019-eular.8098. 2019
Design and Validation of an Expanded Disability Status Scale Model in Multiple Sclerosis.
Barreiro-Gonzalez, Antonio; (...); Casanova, Bonaventura
Article. 10.1159/000519772. 2022
Diagnosis and Treatment Options for Achromatopsia: A Review of the Literature
Pascual-Camps, I; (...); Harto-Castano, M
Review. 10.3928/01913913-20171117-01. 2018
Digital ulcers and cutaneous subsets of systemic sclerosis: Clinical, immunological, nailfold capillaroscopy, and survival differences in the Spanish RESCLE Registry
Tolosa-Vilella, C; (...); RESCLE Investigators
Review. 10.1016/j.semarthrit.2016.04.007. 2016
Does hyaluronidase injected in periocular area change skin ultrastructure?: Standardized in vitro analysis
Aguilar-González M; (...); Pérez-López M
Article. 10.1111/jocd.15014. 2022
Dyschromatopsia in multiple sclerosis reflects diffuse chronic neurodegeneration beyond anatomical landmarks.
Barreiro-González A; (...); Casanova B
Article. 10.1007/s13760-020-01516-x. 2020
Efficacy and Safety of Anakinra Plus Standard of Care for Patients With Severe COVID-19: A Randomized Phase 2/3 Clinical Trial.
Fanlo P; (...); GEAS-SEMI Group
Article. 10.1001/jamanetworkopen.2023.7243. 2023
Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial
Perez-Moreiras, JV; (...); Tocilizumab Graves Orbitopathy Stu
Article. 10.1016/j.ajo.2018.07.038. 2018
EPIDEMIOLOGIC VARIATION ON SCLERODERMA RENAL CRISIS AND CLINICAL FEATURES VARIATION ON SYSTEMIC SCLEROSIS PATIENTS OVER TIME: DATA FROM RESCLE REGISTRY.
Salas, XP; (...); OBORI Autoimmune Dis Study
Meeting Abstract. 10.1136/annrheumdis-2020-eular.1353. 2020
Exposure to different occupational chemicals and clinical phenotype of a cohort of patients with systemic sclerosis.
Freire, Mayka; (...); Simeon-Aznar, Carmen Pilar
Letter. 10.1016/j.autrev.2024.103542. 2024
External clinical validation of automated software to identify structural abnormalities and microhaemorrhages in nailfold videocapillaroscopy images.
Gracia Tello, Borja C; (...); Fanlo, P.
Article. 10.55563/clinexprheumatol/m6obl3. 2023
First clinical symptom as a prognostic factor in systemic sclerosis: results of a retrospective nationwide cohort study
Rubio-Rivas M; (...); Verdejo G
Article. 10.1007/s10067-017-3936-7. 2018
First clinical symptom as a prognostic factor in systemic sclerosis: results of a retrospective nationwide cohort study (vol 37, pg 999, 2018)
Rubio-Rivas, M; (...); RESCLE Investigators
Correction. 10.1007/s10067-018-4179-y. 2018
Fitting Scleral Lenses Less Than 15 mm in Diameter: A Review of the Literature.
Porcar E; (...); Peris-Martínez C
Review. 10.1097/ICL.0000000000000647. 2020
Geographic atrophy: Etiopathogenesis and current therapies.
Sastre-Ibanez M; (...); Garcia-Armendariz B
Article. 10.1016/j.oftal.2017.07.004. 2018
Haematological, biochemical and inflammatory parameters in inactive Behcet's disease. Its association with red blood cell distribution width
Vayá A; (...); Ricart JM
Article. 10.3233/CH-131744. 2014
Hemorheological profile in primary and secondary Raynaud's phenomenon. Influence of microangiopathy
Vayá A; (...); Ricart JM
Article. 10.3233/CH-131723. 2014
Hepatobiliary involvement in systemic sclerosis and the cutaneous subsets: Characteristics and survival of patients from the Spanish RESCLE Registry
Mari-Alfonso, B; (...); Systemic Autoimmune Dis Study Grp
Review. 10.1016/j.semarthrit.2017.10.004. 2018
Homocysteine levels in patients with primary and secondary Raynaud's phenomenon. Its association with microangiopathy severity
Vayá A; (...); Ricart JM
Article. 10.3233/CH-131681. 2014
IgG4-related dacryocystitis and aortitis: A new association.
España-Gregori E; (...); Aguilar-González M
Editorial Material. 10.1177/1120672118823123. 2020
Impact of Corneoscleral Contact Lens Usage on Corneal Biomechanical Parameters in Keratoconic Eyes.
Porcar E; (...); Peris-Martínez C
Article. 10.1097/ICL.0000000000000579. 2019
Increased circulating endothelial cells and microparticles in patients with psoriasis
Martínez-Sales V; (...); Reganon E
Article. 10.3233/CH-131766. 2015
Influence of antibody profile in clinical features and prognosis in a cohort of Spanish patients with systemic sclerosis
Iniesta Arandia N; (...); RESCLE Investigators, Autoimmune D
Article. 2017
Influence of Intravitreal Therapy on Choroidal Thickness in Patients with Diabetic Macular Edema.
Udaondo Mirete P; (...); Espana-Gregori, Enrique
Article. 10.3390/jcm12010348. 2023
INTERSTICTIAL LUNG DISEASE IN SCLERODERMA: SEVERITY ASSOCIATED FACTORS. OBJETIVES
Cano, DS; (...); RESCLE
Meeting Abstract. 10.1136/annrheumdis-2017-eular.2545. 2017
Is erythrocyte sedimentation rate a useful inflammatory marker independently of the hematocrit? Comparison results with plasma viscosity
Letter. 10.3233/CH-141864. 2014
Left ventricular diastolic dysfunction in systemic sclerosis: Clinical, immunological and survival differences in the Spanish RESCLE registry.
González García A; (...); Simeón Aznar CP
Article. 10.1016/j.semarthrit.2022.152033. 2022
LONG -TERM EFFICACY AND SAFETY OF MONOTHERAPY VERSUS COMBINATION THERAPY IN SYSTEMIC SCLEROSIS-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION (PAH): A RETROSPECTIVE COHORT STUDY FROM THE NATIONWIDE SPANISH SCLERODERMA REGISTRY (RESCLE)
Pestana-Fernandez, M; (...); RESCLE
Meeting Abstract. 10.1136/annrheumdis-2018-eular.3560. 2018
Longterm Efficacy and Safety of Monotherapy versus Combination Therapy in Systemic Sclerosis-associated Pulmonary Arterial Hypertension: A Retrospective RESCLE Registry Study.
Pestaña-Fernández M; (...); RESCLE investigators, Autoimmune Diseases Study Group (GEAS)
Article. 10.3899/jrheum.180595. 2020
Lupus nephritis with preserved kidney function associated with poorer cardiovascular risk control: A call for more awareness.
Todoli-Parra JA; (...); Ruiz-Cerda JL
Article. 10.1016/j.hipert.2017.11.002. 2018
Magnetic resonance imaging and optical coherence tomography correlations in multiple sclerosis beyond anatomical landmarks.
Barreiro-González A; (...); Casanova B
Article. 10.1016/j.jns.2020.117180. 2020
Methotrexate as a treatment in ocular cicatricial moderate pemphigoid.
Hervás Ontiveros A; (...); Díaz-Llopis M
Article. 10.1016/j.oftal.2013.10.009. 2014
Multidisciplinary eyelid reconstruction in Barber-Say syndrome: A case report.
Barreiro-González A; (...); Évole-Buselli M
Article. 10.1016/j.oftal.2018.09.009. 2018
Multimodal Evaluation of Visual Function in Geographic Atrophy versus Normal Eyes
Burguera-Gimenez, N; (...); Jonna, G
Article. 10.2147/OPTH.S246245. 2020
Nailfold videocapillaroscopy patterns in systemic sclerosis: implications for cutaneous subsets, disease features and prognostic value for survival.
Tolosa-Vilella, Carles; (...); Simeon-Aznar, Carmen Pilar
Article. 10.55563/clinexprheumatol/8lrofr. 2023
Optic nerve melanocytoma.
Gallego-Pinazo R; (...); Espana-Gregori E
Article. 10.1016/j.oftal.2016.05.014. 2016
Optical Coherence Tomography Characterization of Macular Changes Secondary to Arteriovenous Fistula
Pascual-Camps, I; (...); Espana-Gregori, E
Article. 10.1080/01658107.2017.1371768. 2018
Orbital involvement by non-Hodgkin lymphoma NK T cells.
Hervás-Ontiveros A; (...); Díaz-Llopis M
Article. 10.1016/j.oftal.2013.10.006. 2014
Periorbital necrotising fasciitis secondary to scratching.
Placinta IA; (...); Bort-Martí MÁ
Article. 10.1016/j.oftal.2019.01.005. 2019
Peripapillary capillary network in dominant optic atrophy linked to OPA1 gene
Rahhal-Ortuno, Miriam; (...); Espana-Gregori, Enrique
Article. 10.1177/11206721211044846. 2021
Peripapillary retinal nerve fibre layer correlates better with spinal cord volume than with brain parenchymal fraction in multiple sclerosis
Barreiro-Gonzalez, A; (...); Casanova, B
Meeting Abstract. 2019
Persistent SARS-CoV-2 infection with repeated clinical recurrence in a patient with common variable immunodeficiency.
Cabañero-Navalon MD; (...); Moral, Pedro Moral
Letter. 10.1016/j.cmi.2021.10.021. 2022
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
POLIAUTOIMMUNITY IN SCLERODERMA: DATA FROM DE SPANISH SCLERODERMA REGISTRY
Sanchez-Cano, D; (...); RESCLE
Meeting Abstract. 10.1136/annrheumdis-2018-eular.3545. 2018
Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study
Hervas-Ontiveros, Ana; (...); Cervino, Alejandro
Article. 10.1155/joph/3520219. 2024
Posterior scleral perforation due to endogenous endophthalmitis in a pregnant with selective IgA deficiency.
Aguilar-González M; (...); Espana-Gregori, Enrique
Article. 10.22336/rjo.2022.19. 2022
Proptosis as initial manifestation of Burkitt's lymphoma with orbital involvement.
de Freytas A, Rengel Ruiz M, Espana Gregori E
Article. 10.1016/j.oftal.2016.10.002. 2017
Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery.
Aguilar-Gonzalez, Marina; (...); Peris-Martinez, Cristina
Article. 10.3390/jcm13164769. 2024
Pulmonary hypertension in Spanish patients with systemic sclerosis. Data from the RESCLE registry
Garcia-Hernandez, FJ; (...); Spanish Soc Internal Med SEMI
Article. 10.1007/s10067-018-4390-x. 2019
Purtscher-like retinopathy following carotid angioplasty and stenting in the treatment of severe carotid stenosis.
Solaz-Ruiz, M G; (...); Espana-Gregori, E
Article. 10.1177/11206721231204632. 2023
Rabdomiosarcoma alveolar orbitario enmascarado por sinusitis etmoidal en un adulto de 25 anos.
Sanz-Marco E; (...); Díaz-Llopis M
Abstract of Published Item. 10.1016/j.oftal.2012.10.012. 2014
Rapid-onset voriconazole-induced cicatricial ectropion.
Pérez-López M; (...); Espana-Gregori, E
Article. 10.1016/j.jfo.2021.06.029. 2022
Rate of non-invasive follicular thyroid neoplasms with papillary-like nuclear features depends on pathologist's criteria: a multicentre retrospective Southern European study with prolonged follow-up.
Paja, Miguel; (...); Bella, Rosa M.
Article. 10.1007/s12020-021-02610-7. 2021
Relationship among Corneal Biomechanics, Refractive Error, and Axial Length
Bueno-Gimeno I; (...); Pinero-Llorens DP
Article. 10.1097/OPX.0000000000000231. 2014
REPRODUCIBILITY OF A NEW AUTOMATIC SYSTEM (CAPILLARY.IO) IN THE ANALYSIS OF NAILFOLD CAPILLAROSCOPY IMAGES
Tello, BG; (...); Fanlo, P
Meeting Abstract. 10.1136/annrheumdis-2021-eular.4063. 2021
Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness
Spyropoulos, AC; (...); MARINER Investigators
Article. 10.1056/NEJMoa1805090. 2018
Serodiscordant patients with systemic sclerosis: when antibody does not correspond to skin involvement
Arandia, NI; (...); Aznar, CPS
Article. 2020
Serodiscordant patients with systemic sclerosis: when antibody does not correspond to skin involvement.
Iniesta Arandia N; (...); Simeón Aznar CP
Article. 2020
Simultaneous Pancreas Kidney Transplantation Improves Cardiovascular Autonomic Neuropathy with Improved Valsalva Ratio as the Most Precocious Test
Argente-Pla M; (...); Merino-Torres JF
Article. 10.1155/2020/7574628. 2020
Spanish scleroderma risk score (RESCLESCORE) to predict 15-year all-cause mortality in scleroderma patients at the time of diagnosis based on the RESCLE cohort: Derivation and internal validation
Rubio-Rivas, M; (...); Aznar, CPS
Review. 10.1016/j.autrev.2020.102507. 2020
Standardized incidence ratios and risk factors for cancer in patients with systemic sclerosis: Data from the Spanish Scleroderma Registry (RESCLE).
Carbonell C; (...); Simeón-Aznar CP
Article. 10.1016/j.autrev.2022.103167. 2022
Straatsma Syndrome and cataract: case report and review of the literature.
Blanca, Casado-Pelaez; (...); Enrique, Espana-Gregori
Review. 10.22336/rjo.2023.67. 2023
Symptomatic accommodative and binocular dysfunctions from the use of flat-panel displays
Porcar, E; (...); Espana-Gregori, E
Article. 10.18240/ijo.2018.03.22. 2018
Takayasu's arteritis associated with Crohn's disease.
Tung Chen Y; (...); Nos Mateu P
Article. 10.1016/j.rce.2014.01.012. 2014
Temporal artery biopsy.
Suelves AM, España Gregori E, Díaz-Llopis M
Letter. 10.1016/j.ophtha.2013.08.023. 2013
The challenge of comprehensive nailfold videocapillaroscopy practice: a further contribution.
Gracia Tello B; (...); Fonollosa Pla V
Article. 10.55563/clinexprheumatol/6usce8. 2021
The incidence rate of pulmonary arterial hypertension and scleroderma renal crisis in systemic sclerosis patients with digital ulcers on endothelin antagonist receptors (ERAs) and phosphodiesterase-5 inhibitors (PDE5i).
Pestaña-Fernández M; (...); Simeón-Aznar CP
Article. 10.1093/rheumatology/keaa401. 2021
Tocilizumab as first treatment option in optic neuropathy secondary to Graves' orbitopathy.
Pascual-Camps I; (...); Espana-Gregori E
Article. 10.1080/01676830.2018.1435694. 2018
Toxicity to intravitreal melphalan in a patient with retinoblastoma.
Solaz-Ruiz, Marta Gema; (...); Espana-Gregori, Enrique
Case Reports. 10.22336/rjo.2023.49. 2023
Variations of OCT measurements corrected for the magnification effect according to axial length and refractive error in children
Bueno-Gimeno, I; (...); Zapata-Rodriguez, CJ
Article. 10.1142/S1793545818500013. 2018
Venous thrombosis and relapses in patients with Behcet's disease. Descriptive analysis from Spanish network of Behcet's disease (REGEB cohort)
Rodriguez-Carballeira, M; (...); Cusacovich, I
Article. 2018
Very early and early systemic sclerosis in the Spanish scleroderma Registry (RESCLE) cohort
Trapiella-Martínez L; (...); Simeón-Aznar CP
Review. 10.1016/j.autrev.2017.05.013. 2017
Visual quality with corneo-scleral contact lenses after intracorneal ring segment (ICRS) implantation for keratoconus management
Montalt, JC; (...); Peris-Martinez, C
Article. 10.1016/j.clae.2018.07.006. 2019
Visual quality with corneo-scleral contact lenses for keratoconus management
Montalt, JC; (...); Peris-Martinez, C
Article. 10.1016/j.clae.2018.01.002. 2018
Xantogranuloma necrobiotico. Diagnostico diferencial, tratamiento e implicaciones sistemicas. A proposito de un caso.
Sanz-Marco E; (...); Diaz-Llopis M
Abstract of Published Item. 10.1016/j.oftal.2012.11.007. 2014
Zeus, the look through the anophthalmic cavity.
Placinta IA; (...); España-Gregori E
Article. 10.1016/j.oftal.2019.01.011. 2019