Clinical trial NCT04894890: A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Official title: A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
China
secukinumab
real world study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 1002
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of moderate to severe plaque psoriasis initiating secukinumab will be eligible for this study.

Brief summary: This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.

Detailed description: All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years;
* Diagnosis of clinically moderate to severe plaque-psoriasis;
* Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
* Patient agrees to sign the informed consent

Exclusion Criteria:

- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date

Primary outcomes:
measure: Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
timeFrame: week 24
Secondary outcomes:
measure: Percentage of patients experiencing a 75% reduction of PASI (PASI75)
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Percentage of patients experiencing a 90% reduction of PASI (PASI90)
timeFrame: week 4, week12, week 16, week 36, week 52
measure: Percentage of patients experiencing a 100% reduction of PASI (PASI100)
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Percentage of patients achieved (Body Surface Area) BSA≤1%
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Mean change in Dermatology life quality index (DLQI)
timeFrame: Baseline,week 4, week12, week 16, week 24, week 36, week 52
measure: Percentage of patients achieving DLQI 0 or 1 response
timeFrame: week 4, week12, week 16, week 24, week 36, week 52
measure: Incidence of AEs/SAEs
timeFrame: 52 weeks
measure: Incidence of treatment-related AEs on-treatment and post-discontinuation follow up
timeFrame: 52 weeks
measure: Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up
timeFrame: 52 weeks
measure: Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up
timeFrame: 52 weeks
measure: Incidence of AEs of special interest on-treatment and post discontinuation follow up
timeFrame: 52 weeks
measure: Proportion of patients experiencing at least one AE
timeFrame: 52 weeks
measure: Average number of AEs per patient
timeFrame: 52 weeks
measure: Percentage of secukinumab discontinuation caused by AE
timeFrame: 52 weeks
measure: Frequency distribution of patients by dosing pattern
timeFrame: 52 weeks
measure: Frequency distribution of patients by secukinumab retention
timeFrame: Week 4, week 12, week 16, week 24, week 36 and week 52
measure: Mean (SD) time to secukinumab discontinuation
timeFrame: Up to 52 weeks
measure: Median (interquartile range) time to secukinumab discontinuation
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Xicheng Direct
country: China
facility: Novartis Investigative Site
state: Beijing
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Lanzhou
country: China
facility: Novartis Investigative Site
state: Gansu
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shen Zhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shenzhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangdong
country: China
facility: Novartis Investigative Site
state: Guangzhou
city: Haikou
country: China
facility: Novartis Investigative Site
state: Hainan
city: Handan
country: China
facility: Novartis Investigative Site
state: Hebei
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha City
country: China
facility: Novartis Investigative Site
state: Hunan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Xuzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Yinchuan
country: China
facility: Novartis Investigative Site
state: Ningxia
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Qingdo
country: China
facility: Novartis Investigative Site
state: Shandong
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Taiyuan
country: China
facility: Novartis Investigative Site
state: Shanxi
city: XI An
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Xian
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Nanjing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanyang
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Wuhan
country: China
facility: Novartis Investigative Site
city: Zhejiang
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: