A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate

ovartis Pharma AG0 个研究点目标入组 215 人开始时间: 2011年9月7日最近更新: 2014年11月3日

适应症

试验速览

暂无简介。

•- Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months before screening
•- Must have been taking Methotrexate for at least 3 months before randomization and must currently be on a stable dose of Methotrexate for at least 4 weeks before randomization
•- At baseline : disease activity criteria defined by = 6 tender joints out of 68 and = 6 swollen joints out of 66 and with at least 1 of the following at screening: anti-CCP antibodies positive or rheumatoid factor positive and with at least 1 of the following at screening: hsCRP = 10 mg/L or ESR = 28 mm/1st hr
•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 172
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 43

•- Rheumatoid arthritis patients functional status class IV according to the ACR 1991 revised criteria
•- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
•- Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
•- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
•- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization.
•Other protocol-defined exclusion criteria may apply.

发起方