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FUTURE 2A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Secukinumab (AIN457)

+ Placebo

Medicamento
Quiénes están siendo reclutados

Artritis+6

+ Enfermedades de los Huesos

+ Enfermedades de las Articulaciones

A partir de 18 años
+16 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 3
Intervencional
Inicio del estudio: abril de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNovartis Pharmaceuticals
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 14 de abril de 2013

Fecha en la que se inscribió al primer participante.

At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups. * 75 mg secukinumab * 150 mg secukinumab * 300 mg secukinumab * Placebo At Week 16, all subjects were classified as responders (≥ 20% improvement from BSL in both tender and swollen joint counts) or non-responders. Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial. Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows: Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16. Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24. This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards. An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.

Título OficialA Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
NCT01752634
Patrocinador PrincipalNovartis Pharmaceuticals
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 397 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

ArtritisEnfermedades de los HuesosEnfermedades de las ArticulacionesEnfermedades del sistema musculoesqueléticoPsoriasisEnfermedades de la PielEnfermedades de la columna vertebralEspondilitisArtritis Psoriásica

Criterios

6 criterios de inclusión requeridos para participar
Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

Rheumatoid factor and anti-CCP antibodies negative at screening

Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis

Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs

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10 criterios de exclusión impiden participar
Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)

Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor

Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash out periods need to be observed:

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

4 grupos de intervención están designados en este estudio

25% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Placebo
Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.

Grupo II

Experimental
Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Grupo III

Experimental
Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4

Grupo IV

Experimental
Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 76 ubicaciones

Suspendido

Novartis Investigative Site

Peoria, United StatesAbrir Novartis Investigative Site en Google Maps
Suspendido

Novartis Investigative Site

Aventura, United States
Suspendido

Novartis Investigative Site

Palm Harbor, United States
Suspendido

Novartis Investigative Site

Sarasota, United States
Completado76 Centros de Estudio