Phase
Condition
Psoriasis And Psoriatic Disorders
Joint Injuries
Psoriatic Arthritis
Treatment
Secukinumab Placebo
AIN457
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be able to understand and communicate with the investigator andcomply with the requirements of the study and must give a written, signed and datedinformed consent before any study assessment is performed.
Chinese male or non-pregnant, non-lactating Chinese female participants at least 18years of age.
Diagnosis of PsA classified by Classification of Psoriatic Arthritis (CASPAR)criteria and with symptoms for at least 6 months with moderate to severe Psoriaticarthritis (PsA).
Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodiesnegative at screening.
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or adocumented history of plaque psoriasis.
Participants on Methotrexate (MTX) must be on folic acid supplementation atrandomization.
Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeksprior to randomization visit except for leflunomide, which has to be discontinuedfor 8 weeks prior to randomization unless a cholestyramine washout has beenperformed.
Exclusion
Exclusion Criteria:
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
Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone,morphine).
Previous exposure to secukinumab or other biologic drug directly targetinginterleukin- 17 (IL-17) or IL-17 receptor
Participants who have ever received biologic immunomodulating agents except forthose targeting Tumor necrosis factor alpha (TNFα).
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using effective contraception during the entirestudy (during the entire study).
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Chongqing, Chongqing 400010
ChinaSite Not Available
Novartis Investigative Site
Guang Zhou, Guang Dong Province 510120
ChinaSite Not Available
Novartis Investigative Site
Guangzhou, Guangdong 510515
ChinaSite Not Available
Novartis Investigative Site
Wuhan, Hubei 430030
ChinaSite Not Available
Novartis Investigative Site
Zhuzhou, Hunan 412000
ChinaSite Not Available
Novartis Investigative Site
Baotou, Inner Mongolia 014010
ChinaSite Not Available
Novartis Investigative Site
Hohhot, Inner Mongolia 10050
ChinaSite Not Available
Novartis Investigative Site
Nanjing, Jiangsu 210008
ChinaSite Not Available
Novartis Investigative Site
Nanchang, Jiangxi 330006
ChinaSite Not Available
Novartis Investigative Site
Pingxiang, Jiangxi 337000
ChinaSite Not Available
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaSite Not Available
Novartis Investigative Site
Urumqi, Xinjiang 830001
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100730
ChinaSite Not Available
Novartis Investigative Site
Jinan, 250012
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200127
ChinaSite Not Available
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