A 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. - FUTURE-2

ovartis Pharma Services AG0 个研究点目标入组 400 人开始时间: 2012年12月18日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•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 • Subjects taking corticosteroids must be on a stable dose of =10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24 • Subjects taking MTX (= 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
•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 320
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•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: • Oral or topical retinoids 4 weeks • Photochemotherapy (e.g. PUVA) 4 weeks • Phototherapy (UVA or UVB) 2 weeks • Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa, investigational or approved • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

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