{"ctNumber":"2024-513123-17-00","ctStatus":"Ended","startDateEU":"2022-01-12","endDateEU":"2025-11-26","decisionDate":"2024-04-15T12:46:56.409","publishDate":"2025-12-03T02:31:00.71228822","ctPublicStatusCode":8,"authorizedApplication":{"authorizedPartI":{"id":70054,"rowSubjectCount":0,"products":[{"id":285892,"part1MpRoleTypeCode":"3","productDictionaryInfo":{"euMpNumber":"SUB08856MIG","marketingAuthNumber":"-","prodAuthStatus":2,"prodName":"METHOTREXATE","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","activeSubstanceName":"METHOTREXATE","euSubstNumber":"SUB08856MIG","productSubstances":[{"substancePk":"233086","actSubstOrigin":"Chemical","actSubstName":"METHOTREXATE","substanceEvCode":"SUB08856MIG"}],"atcCode":"-","atcName":"-","atcTermLevel":"-","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"20","doseUomTotal":"mg 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ANTERIOR UVEITIS: A MULTICENTER, RANDOMIZED, PARALLEL 3 ARMS, ACTIVE-CONTROLLED, PHASE 3 OPEN LABEL WITH BLINDED OUTCOME ASSESSMENT STUDY.","publicTitleTranslations":[{"id":5044323,"uuid":"1ae60b0f-b715-40fd-b7af-0e86a298097b","attributeTranslation":"Eficacia, seguridad y coste-efectividad del metotrexato, adalimumab, o su combinación en uveítis no anterior no infecciosa: un estudio multicéntrico, aleatorizado, paralelo de 3 brazos, con control activo, de fase 3, abierto, con evaluador cegado: Co-THEIA","language":7,"languageDescription":"Spanish"}],"secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":true,"trialPhase":"5","trialCategory":"3","justificationForTrialCategory":"Low interventional study","trialCategoryId":61666},"medicalCondition":{"partIMedicalConditions":[{"id":70744,"medicalCondition":"Non-infection uveitis","medicalConditionTranslations":[{"id":5044280,"uuid":"250665b3-017c-4d78-8828-ef9553749156","attributeTranslation":"uveitis no infecciosa","language":7,"languageDescription":"Spanish"}],"isConditionRareDisease":true}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":203543}],"mainObjective":"To compare the proportion of patients achieving a Good Clinical Response by week 16 that is maintained in every study visit until week 52","mainObjectiveTranslations":[{"id":5044322,"uuid":"d59d65d1-d447-4a42-ac43-55aaf1bf59c4","attributeTranslation":"Comparar la proporción de pacientes que logran una buena respuesta clínica en la semana 16 que se mantiene en cada visita de estudio hasta la semana 52","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":229554,"number":1,"secondaryObjective":"To compare the clinical components of the Good Clinical Response variable between treatment strategies (see section 12.1 for a complete list of the components)","secondaryObjectiveTranslations":[{"id":5044324,"uuid":"fa4b9fcf-5037-4227-a32e-cfd1fff27c93","attributeTranslation":"Comparar los componentes clínicos de la variable buena respuesta clínica entre las estrategias de tratamiento","language":7,"languageDescription":"Spanish"}]},{"id":229555,"number":2,"secondaryObjective":"To compare the proportion of patients achieving a Good Clinical Response by week 16","secondaryObjectiveTranslations":[{"id":5044325,"uuid":"089bca85-01e3-48c8-a499-6d94fa977f72","attributeTranslation":"Comparar la proporción de pacientes que logran una buena respuesta clínica en la semana 16","language":7,"languageDescription":"Spanish"}]},{"id":229556,"number":3,"secondaryObjective":"To compare several Patient Reported Outcomes Measures (health- and vision-related quality of life, anxiety and depression) between treatment strategies","secondaryObjectiveTranslations":[{"id":5044326,"uuid":"5edc76b8-7922-4bd2-ae88-5ff492730c73","attributeTranslation":"Comparar varias medidas de resultados informados por el paciente (calidad de vida relacionada con la salud y la visión, ansiedad y depresión) entre las estrategias de tratamiento","language":7,"languageDescription":"Spanish"}]},{"id":229557,"number":4,"secondaryObjective":"To compare the time to relapse after week 16 between treatment strategies","secondaryObjectiveTranslations":[{"id":5044327,"uuid":"6274260a-c01d-4866-98db-c2ae86d77db9","attributeTranslation":"Comparar el tiempo de recaída después de la semana 16 entre las estrategias de tratamiento","language":7,"languageDescription":"Spanish"}]},{"id":229558,"number":5,"secondaryObjective":"To compare the evolution of the activity disease score in patients with uveitis (UVEDAI) between treatment strategies","secondaryObjectiveTranslations":[{"id":5044328,"uuid":"e6b427d0-1f92-484e-8e34-5f000e09505b","attributeTranslation":"Comparar la evolución del score de actividad de la enfermedad en pacientes con uveítis (UVEDAI) entre estrategias de tratamiento.","language":7,"languageDescription":"Spanish"}]},{"id":229559,"number":6,"secondaryObjective":"To assess the safety of each treatment strategy","secondaryObjectiveTranslations":[{"id":5044329,"uuid":"63292a49-563b-4463-a28c-0e92d71b1446","attributeTranslation":"Evaluar la seguridad de cada estrategia de tratamiento","language":7,"languageDescription":"Spanish"}]},{"id":229560,"number":7,"secondaryObjective":"To assess the cost-utility and cost-effectiveness from both a Health System and a Societal perspectives of the combination therapy and the ADA monotherapy compared with MTX given alone","secondaryObjectiveTranslations":[{"id":5044330,"uuid":"0f3daf20-c170-495e-bc33-0badac4cf484","attributeTranslation":"Evaluar coste-utilidad y coste-eficacia desde la perspectiva del Sistema de Salud y de la Sociedad de la terapia combinada y la monoterapia con ADA en comparación con la monoterapia con MTX","language":7,"languageDescription":"Spanish"}]},{"id":229561,"number":8,"secondaryObjective":"To identify genetic and proteomic multiomic biomarkers (including genetic, transcriptomic, proteomic, epigenetic and metabolomic) associated with clinical manifestations, diagnosis and drug response to each treatment strategy. In addition, we will carry out a substudy with the objective of building a public access biobank with peripheral blood derived samples to carry out future studies in uveitis.","secondaryObjectiveTranslations":[{"id":5044331,"uuid":"310a0595-2532-48f1-9e85-df7828cafd5c","attributeTranslation":"Identificar biomarcadores multiómicos (incluyendo genéticos, transcriptómicos, proteómicos, epigenéticos y metabolómicos) asociados con manifestaciones clínicas, diagnóstico y respuesta del fármaco a cada estrategia de tratamiento. Además, se planteará un subestudio cuyo objetivo sea la construcción de un biobanco de acceso público con muestras derivadas de sangre periférica para llevar a cabo futuros estudios sobre la uveítis","language":7,"languageDescription":"Spanish"}]},{"id":229562,"number":9,"secondaryObjective":"To generate deep learning models based on convolutional neural networks to automatically quantify image biomarkers related to clinical manifestations, diagnosis and pharmacological response.","secondaryObjectiveTranslations":[{"id":5044332,"uuid":"91b49691-fbcc-4399-8dce-cfc062adc7de","attributeTranslation":"Generar modelos de aprendizaje profundo basados ​​en redes neuronales convolucionales para cuantificar automáticamente biomarcadores de imagen relacionados con manifestaciones clínicas, diagnóstico y respuesta farmacológica.","language":7,"languageDescription":"Spanish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":446116,"number":1,"principalInclusionCriteria":"Subjects diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis in at least one eye","principalInclusionCriteriaTranslations":[{"id":5044313,"uuid":"f7a54eca-1d2f-445b-8440-b31bc51a4f7e","attributeTranslation":"Subjects diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis in at least one eye","language":7,"languageDescription":"Spanish"}]},{"id":446117,"number":2,"principalInclusionCriteria":"Adult patients (≥18 years)","principalInclusionCriteriaTranslations":[{"id":5044314,"uuid":"cecdf9fe-fe3a-42c1-93b9-3105145dc671","attributeTranslation":"Adultos (mayores de 18 años)","language":7,"languageDescription":"Spanish"}]},{"id":446118,"number":3,"principalInclusionCriteria":"Subjects with at least one flare of active eye inflammation in the previous 180 days before Baseline visit, defined by the presence of at least 1 of the following parameters in either eye: a. Active chorioretinal or retinal vascular lesion, AND/OR b. Presence of macular edema by optical coherence tomography (OCT: thickness >350 μm when measured with spectralis or >340 μm when measured with Cirrus or TopCon, AND cysts or intraretinal fluid), AND/OR c. ≥ 2+ anterior chamber cells (ACC; SUN criteria4) , AND/OR d. ≥ 2+ vitreous haze (National Eye Institute [NEI]113/SUN criteria).","principalInclusionCriteriaTranslations":[{"id":5044315,"uuid":"f752bd42-3364-4060-8438-ddfaffcbcc44","attributeTranslation":"Sujetos con inflamación ocular activa en los 180 días previos a la Visita Basal, definidos por la presencia de al menos 1 de los siguientes parámetros en cualquiera de los ojos: Lesión vascular coriorretiniana o retiniana activa, Y/O\nPresencia de edema macular por tomografía de coherencia óptica (OCT: espesor > 350 μm medido con spectralis o > 340 μm medido con Cirrus o TopCon, Y quistes o líquido intrarretiniano) y evidencia de inflamación intraocular, Y/O ≥ 2+ células de la cámara anterior (CCA; criterio SUN), Y/O  ≥ 2+ vitritis (National Eye Institute [NEI] 73/criterio SUN)","language":7,"languageDescription":"Spanish"}]},{"id":446119,"number":4,"principalInclusionCriteria":"Subjects with active eye inflammation at Baseline visit, defined by the presence of at least 1 of the following parameters in either eye: a. Active chorioretinal or retinal vascular lesion, AND/OR b. Presence of macular edema by OCT (thickness >350 μm when measured with spectralis or >340 μm when measured with Cirrus or TopCon AND cysts or intraretinal fluid), AND/OR c. ≥ 1+ ACC, AND/OR d. ≥ 1+ vitreous haze.","principalInclusionCriteriaTranslations":[{"id":5044316,"uuid":"6886c8f5-226f-46e7-a1e7-7fe388fce045","attributeTranslation":"Sujetos con inflamación ocular activa en la Visita Basal, definida por la presencia de al menos 1 de los siguientes parámetros en cualquiera de los ojos:Lesión vascular coriorretiniana o retiniana activa, Y/O Presencia de edema macular por tomografía de coherencia óptica (OCT: espesor> 350 μm medido con spectralis o > 340 μm medido con Cirrus o TopCon Y quistes o líquido intrarretiniano), Y/O ≥ 1+ CCA, Y/O  ≥ 1+ vitritis","language":7,"languageDescription":"Spanish"}]},{"id":446120,"number":5,"principalInclusionCriteria":"Subjects meeting at least ONE of the following criteria: a. Subjects with known chronic condition necessitating GCs-sparing immunosuppressive treatment: multifocal choroiditis with panuveitis, serpiginous choroidopathy, birdshot retinochoroidopathy, diffuse retinal vasculitis, Vogt-Koyanagi-Harada with bullous serous retinal and/or choroidal detachments, sympathetic ophthalmia. No prior therapy is required for these patients. AND/OR b. Intermediate uveitis fulfilling the following characteristics:  Bilateral disease, AND,  Low visual acuity (best corrected visual acuity <0.5) OR  Bilateral macular involvement, defined as presence of macular edema (as defined in Inclusion Criteria 3, subpoint (b)), macular atrophy, and/or macular scarring. No prior therapy is required for these patients. AND/OR c. Subjects with registered local/systemic corticosteroid refractory uveitis in the previous 180 days months before Baseline visit, defined as:  Presence of active inflammation after 4 weeks of high-dose (1mg/kg prednisone equivalent, see equivalence Table 6) corticosteroid treatment, resulting in an incomplete response (there was an amelioration, but there is still inflammation); AND/OR,  Presence of active inflammation 4 weeks after a regional corticosteroid injection; AND/OR,  Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by relapse [increase in ≥1 grade in ACC or vitreous haze or a change of non-active to active lesions (including chorioretinal or retinal vascular lesion and/or macular edema)] when GCs was tapered; AND/OR,  Presence of active inflammation after a long-acting corticosteroid intramuscular injection administered between 4 weeks to 180 days before the Baseline visit); AND/OR,  Active inflammation after treatment with >10mg/day oral prednisone for at least the past 90 days before Baseline.","principalInclusionCriteriaTranslations":[{"id":5044317,"uuid":"a7950d86-4b33-42f9-b5c7-897202c7185f","attributeTranslation":"Sujetos que cumplan al menos UNO de los siguientes criterios: A) Sujetos con enfermedades crónicas que habitualmente van a requerir un tratamiento inmunosupresor ahorrador de CS: coroiditis multifocal con panuveitis, coroidopatía serpiginosa, retinocoropatía de Birdshot, vasculitis retiniana difusa, síndrome de Vogt-Koyanagi-Harada con desprendimiento seroso retiniano y/o coroideo Y/O oftalmía simpática. No se requiere terapia previa en estos pacientes. B)Uveítis intermedia que cumple las siguientes características: Enfermedad bilateral, Y, Agudeza visual baja (mejor agudeza visual corregida <0,5) O Afectación macular bilateral, definida como la presencia de edema macular (como se define en los Criterios de inclusión 3, subpunto (b)), atrofia macular y/o cicatrización macular. No se requiere terapia previa para estos pacientes. C) Sujetos con uveítis y fallo registrado en los 180 días previos a la Visita Basal a CS locales o sistémicos, definido como: Inflamación activa después de 4 semanas de tratamiento con corticosteroides en dosis altas (1 mg/kg de prednisona o equivalente), lo que resulta en una respuesta incompleta (hubo una mejoría, pero todavía hay inflamación); Y/O Inflamación activa 4 semanas después de una inyección periocular de corticosteroides; Y/O Tratamiento con corticosteroides orales que resulta en una reducción de la inflamación, seguida de una recaída cuando la dosis de CS fue reducida [aumento en ≥1 grado en CCA o vitritis o un cambio de lesiones no activas a activas (incluidas lesiones vasculares coriorretinianas o retinianas Y/O edema macular)]; Y/O Inflamación activa después de la inyección intramuscular de corticosteroides de acción prolongada entre 4 semanas y 180 días antes de la Visita Basal); Y/O Inflamación activa después del tratamiento con > 10 mg/día de prednisona oral durante al menos los últimos 90 días antes del inicio.","language":7,"languageDescription":"Spanish"}]},{"id":446121,"number":6,"principalInclusionCriteria":"If female, subject is: a. Not of childbearing potential: at least 1 year or more since the final menstrual period or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); b. Of childbearing potential and willing to use an acceptable method of contraception during the study period (i.e. pharmacologics, devices, barrier methods) or abstinence, and for 150 days after the last dose of study drugs; For the purpose of this clinical trial, woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. c. Not pregnant or breastfeeding","principalInclusionCriteriaTranslations":[{"id":5044318,"uuid":"86e95f65-fc63-4e28-9d46-d2b21f3eb105","attributeTranslation":"Si es mujer, el sujeto:A) No tiene potencial para tener hijos (posmenopáusica durante al menos 1 año o quirúrgicamente estéril (ligadura de trompas bilateral, ooforectomía bilateral o histerectomía); B) Tiene potencial para tener hijos y está dispuesta a utilizar un método anticonceptivo aceptable durante el período de estudio y los 150 días después de la última dosis de la medicación del estudio (incluyendo métodos farmacológicos, dispositivos y de barrera) o abstinencia; C) No embarazada ni en periodo de lactancia","language":7,"languageDescription":"Spanish"}]},{"id":446122,"number":7,"principalInclusionCriteria":"Subject has a negative tuberculosis skin test (PPD test or equivalent) and non-pathological Chest X-ray (CXR; Posterior-anterior and lateral view) at Screening or in the previous 90 days before Baseline visit. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement and/or a CXR consistent with prior tuberculosis (TB) exposure, the subject must initiate, be currently receiving or have documented completion of a course of prophylactic anti-TB therapy","principalInclusionCriteriaTranslations":[{"id":5044319,"uuid":"803db5aa-a2eb-445d-8c0f-b4884aad4bce","attributeTranslation":"El sujeto tiene una prueba PPD negativa (o equivalente) y una radiografía de tórax no patológica (CXR; vista posterior-anterior y lateral) en el examen de detección o en los 90 días previos a la Visita Basal. Si el sujeto tiene una prueba de PPD positiva (o equivalente), ha tenido una reacción ulcerosa en el pasado a la colocación de PPD Y/O un CXR consistente con la exposición previa a la tuberculosis (TB), el sujeto debe iniciar, estar recibiendo o haber documentado la finalización de un curso de terapia profiláctica contra la tuberculosis (consulte la sección \"Procedimientos de estudio\"). El tratamiento profiláctico debe iniciarse al menos 4 semanas antes de la Visita Basal.","language":7,"languageDescription":"Spanish"}]},{"id":446123,"number":8,"principalInclusionCriteria":"Subjects able and willing to provide written informed consent and to comply with the study protocol.","principalInclusionCriteriaTranslations":[{"id":5044320,"uuid":"a60a28bd-808c-40c9-aa93-15a908008e50","attributeTranslation":"Sujetos capaces y dispuestos a dar su consentimiento informado por escrito y cumplir con el protocolo del estudio.","language":7,"languageDescription":"Spanish"}]},{"id":446124,"number":9,"principalInclusionCriteria":"Do not participate in another clinical trial","principalInclusionCriteriaTranslations":[{"id":5044321,"uuid":"8fdd0398-68fc-43e5-a6c2-34f14c4d159d","attributeTranslation":"No incluidos en otro ensayo clínico","language":7,"languageDescription":"Spanish"}]}],"principalExclusionCriteria":[{"id":768400,"number":1,"principalExclusionCriteria":"Subjects with confirmed or suspected infectious uveitis, including ocular histoplasmosis syndrome","principalExclusionCriteriaTranslations":[{"id":5044295,"uuid":"51b30ab0-0552-42f7-9881-d3d8fd082e17","attributeTranslation":"Sujetos con uveítis infecciosa confirmada o sospechada, incluido el síndrome de histoplasmosis ocular","language":7,"languageDescription":"Spanish"}]},{"id":768401,"number":10,"principalExclusionCriteria":"Subjects with a history of prior intraocular surgery within 30 days prior to the Baseline visit, AND/OR any planned eye surgery within the next 52 weeks from Baseline Visit","principalExclusionCriteriaTranslations":[{"id":5044296,"uuid":"ba01e9c0-4f68-4cb2-9c96-7e2c203ebab7","attributeTranslation":"Sujetos con antecedentes de cirugía intraocular previa dentro de los 30 días previos a la Visita Basal, Y/O cualquier cirugía ocular planificada (electiva) dentro de las próximas 52 semanas desde la Visita Basal;","language":7,"languageDescription":"Spanish"}]},{"id":768402,"number":11,"principalExclusionCriteria":"Subjects with best spectacle-corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR > 1.34) in the better eye during the screening or at Baseline visit","principalExclusionCriteriaTranslations":[{"id":5044297,"uuid":"c548fb4f-6fd6-40da-ae2c-6326a389fa8a","attributeTranslation":"Sujetos con mejor agudeza visual corregida (AVC) < 20/400 (ETDRS logMAR> 1.34) en el mejor ojo","language":7,"languageDescription":"Spanish"}]},{"id":768403,"number":12,"principalExclusionCriteria":"Subjects with active malignancy considered by the Site’s Investigator, and confirmed or suspected ocular masquerade syndromes","principalExclusionCriteriaTranslations":[{"id":5044298,"uuid":"2945cb93-8f41-428b-9e4a-4d11da909cbe","attributeTranslation":"Sujetos con antecedentes de malignidad, como linfoma, leucemia, cáncer de piel no melanoma y síndromes de mascarada ocular confirmados o sospechosos","language":7,"languageDescription":"Spanish"}]},{"id":768404,"number":13,"principalExclusionCriteria":"Subjects with systemic autoimmune disease or ocular condition (besides uveitis) anticipated to dictate treatment course, as considered by the Site’s Investigator","principalExclusionCriteriaTranslations":[{"id":5044299,"uuid":"9e612b70-266c-4bda-8b95-3814a5a29829","attributeTranslation":"Sujetos con enfermedad autoinmune sistema u ocular (además de la uveitis) en los que se prevé que vaya a dictar el curso del tratamiento durante el periodo del estudio","language":7,"languageDescription":"Spanish"}]},{"id":768405,"number":14,"principalExclusionCriteria":"Subjects with infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit","principalExclusionCriteriaTranslations":[{"id":5044300,"uuid":"19527329-3eb0-4da5-99b0-daac0360dab6","attributeTranslation":"Sujetos con una infección que haya requerido tratamiento con antiinfecciosos intravenosos (IV) dentro de los 30 días previos a la Visita Basal o antiinfecciosos orales dentro de los 14 días anteriores a la Visita Basal","language":7,"languageDescription":"Spanish"}]},{"id":768406,"number":15,"principalExclusionCriteria":"Subjects with systemic active or chronic recurring infections, such as active TB (If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement and/or a CXR consistent with prior tuberculosis (TB) exposure, the subject must initiate, be currently receiving or have documented completion of a course of prophylactic anti-TB therapy (see “Study Procedures” section)), syphilis, or hepatitis B or C, at Screening visit or in the previous 90 days before Baseline visit; AND/OR a history of invasive infection (e.g., listeriosis and histoplasmosis)","principalExclusionCriteriaTranslations":[{"id":5044301,"uuid":"bfbfbbc4-5f7a-417a-a2f8-477d3e84d116","attributeTranslation":"Sujetos con infecciones sistémicas activas o recurrentes/crónicas, como TB activa, sífilis o hepatitis B o C, en el periodo de cribado o en los 90 días anteriores a la Visita Basal; Y/O antecedentes de infección invasiva (p. Ej., Listeriosis e histoplasmosis)","language":7,"languageDescription":"Spanish"}]},{"id":768407,"number":16,"principalExclusionCriteria":"Subjects with history of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident (6 months) and any other condition which, in the opinion of the Site’s Investigator, would put the subject at risk by participation in the study","principalExclusionCriteriaTranslations":[{"id":5044302,"uuid":"6f7d39b6-f8f8-4040-adef-1f33e07097da","attributeTranslation":"Sujetos con antecedentes de insuficiencia cardíaca congestiva moderada o grave (clase III o IV de la NYHA), accidente cerebrovascular reciente y cualquier otra afección que, en opinión del Investigador, pondría al sujeto en riesgo al participar en el estudio","language":7,"languageDescription":"Spanish"}]},{"id":768408,"number":17,"principalExclusionCriteria":"Subjects with clinically significant abnormal screening laboratory results as evaluated by the Site’s Investigator (at screening/baseline or in the previous 4 weeks).","principalExclusionCriteriaTranslations":[{"id":5044303,"uuid":"a2aeea87-6642-4da5-9a04-23466b3ed057","attributeTranslation":"Sujetos con resultados de laboratorio alterados de manera clínicamente significativa según la evaluación del Investigador durante el periodo de cribado o en las 4 semanas anteriores","language":7,"languageDescription":"Spanish"}]},{"id":768409,"number":18,"principalExclusionCriteria":"Central nervous system demyelinating disease: a. Subjects with history of Central nervous system demyelinating disease AND/OR b. Magnetic Resonance Imaging (MRI) findings suggestive of a demyelinating disease: All subjects with intermediate uveitis or panuveitis that have signs of intermediate uveitis (e.g., presence or history of snowbanking or snowballs) must have a brain MRI within 90 days prior to the Baseline visit.","principalExclusionCriteriaTranslations":[{"id":5044304,"uuid":"a847ff69-4ad5-4d63-b611-af2cc2664337","attributeTranslation":"Enfermedades desmielinizantes que afectan el sistema nervioso central: Sujetos con antecedentes o síntomas neurológicos sugerentes de enfermedad desmielinizante del sistema nervioso central Y/O Resonancia magnética (RNM) que sugieren una enfermedad desmielinizante como la esclerosis múltiple. 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