A RANDOMIZED, PARTIALLY-BLINDED, ACTIVE-CONTROLLED MULTICENTER STUDY OF SECUKINUMAB TO DEMONSTRATE REDUCTION OF RADIOGRAPHIC PROGRESSION VERSUS GP2017 (ADALIMUMAB BIOSIMILAR) AT 104 WEEKS AND TO ASSESS THE LONG TERM SAFETY, TOLERABILITY AND EFFICACY UP TO 2 YEARS IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS.

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 35 人开始时间: 2018年6月20日最近更新: 2023年11月13日

适应症

试验速览

暂无简介。

•1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
•2. Male or non-pregnant, non-lactating female patients at least 18 years of age
•3. Diagnosis of moderate to severe AS with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS (Appendix 3)
•4. Active AS assessed by total BASDAI ≥ 4 (0-10) at Baseline
•5. Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10) at Baseline
•6. Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline

•1. Pacientes con anquilosis total de la columna vertebral.
•2. Radiografia de torax o RM de torax con evidencia de un proceso infeccioso o maligno en curso, que se deben obtener en un plazo de 3 meses antes de la seleccion y deben ser evaluadas por un medico calificado.
•3. Exposicion previa al secukinumab, al adalimumab o a cualquier otro agente biologico inmunomodulador, incluidos los dirigidos a la IL-17, al receptor de IL-17 o al TNFα.
•4. Pacientes que tomen analgesicos opioides de alta potencia (p. ej., metadona, hidromorfona, morfina y oxicodona).
•5. Uso de dispositivos o farmacos en investigacion dentro de las 4 semanas de la aleatorizacion o un periodo de 5 vidas medias del farmaco en investigacion, lo que sea mas prolongado.
•6. Antecedentes de hipersensibilidad a cualquiera de los farmacos del estudio o a farmacos de clases quimicas similares.

发起方

OVARTIS BIOSCIENSES PERU S.A.,