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 - SURPASS

ovartis Pharma AG0 个研究点目标入组 837 人开始时间: 2018年12月19日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•- Male or non-pregnant, non-nursing female patients at least 18 years of age.
•- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy.
•- Active AS assessed by total BASDAI = 4 on a scale of 0-10.
•- Spinal pain as measured by BASDAI question #2 = 4 (0-10).
•- Total back pain as measured by visual analog scale (VAS) = 40 mm (0-100 mm).
•- hsCRP = 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.
•Other protocol-defined inclusion criteria may apply,
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 753
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•- Patients with total ankylosis of the spine.
•- Pregnant or nursing (lactating) women.
•- Evidence of ongoing infectious or malignant process.
•- Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFa.
•- Subjects taking high potency opioid analgesics.
•- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.
•Other protocol-defined exclusion criteria may apply,

发起方