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, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFÎ± agents

ovartis Healthcare Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subject 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 subjects at least 18 years of age
•3. Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) for at
•least 3 months before screening
•At Baseline: Disease activity criteria defined by >=6 tender joints out of 68 and >= 6
•swollen joints out of 66
•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
•4. Subjects must have been taking at least one anti-TNF-Î± agent such as etanercept,
•adalimumab, infliximab, certolizumab or golimumab given at an approved dose for
•at least 3 months before randomization and have experienced an inadequate
•response to treatment or have been intolerant to at least one administration of an
•anti-TNF-Î± agent

•1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process,
•obtained within 3 months prior to screening and evaluated by a qualified physician
•2. RA subjects functional status class IV according to the ACR 1991 revised criteria
•(see Appendix 3)
•3. Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
•4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17
•or IL-17 receptor
•5. Use of any investigational drug and/or devices within 4 weeks before
•randomization, or a period of 5 half-lives of the investigational drug, whichever is

发起方

ovartis Healthcare Pvt Ltd