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
UNMASK2
1 other identifier
observational
1,002
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
September 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedMarch 20, 2024
March 1, 2024
2.2 years
May 18, 2021
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
week 24
Secondary Outcomes (21)
Percentage of patients experiencing a 75% reduction of PASI (PASI75)
week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients experiencing a 90% reduction of PASI (PASI90)
week 4, week12, week 16, week 36, week 52
Percentage of patients experiencing a 100% reduction of PASI (PASI100)
week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5
week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1
week 4, week12, week 16, week 24, week 36, week 52
- +16 more secondary outcomes
Study Arms (1)
secukinumab
Patients administered secukinumab by prescription
Interventions
There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Eligibility Criteria
Patients with confirmed diagnosis of moderate to severe plaque psoriasis initiating secukinumab will be eligible for this study.
You may qualify if:
- 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
You may not qualify if:
- \- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Novartis Investigative Site
Xicheng Direct, Beijing Municipality, 100044, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010, China
Novartis Investigative Site
Lanzhou, Gansu, 730030, China
Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
Novartis Investigative Site
Shenzhen, Guangdong, 518020, China
Novartis Investigative Site
Shenzhen, Guangdong, 518116, China
Novartis Investigative Site
Guangdong, Guangzhou, 510091, China
Novartis Investigative Site
Haikou, Hainan, 571127, China
Novartis Investigative Site
Handan, Hebei, 056002, China
Novartis Investigative Site
Zhengzhou, Henan, 450003, China
Novartis Investigative Site
Wuhan, Hubei, 430030, China
Novartis Investigative Site
Changsha, Hunan, 410003, China
Novartis Investigative Site
Changsha, Hunan, 410011, China
Novartis Investigative Site
Suzhou, Jiangsu, 215006, China
Novartis Investigative Site
Xuzhou, Jiangsu, 221003, China
Novartis Investigative Site
Changchun, Jilin, 130041, China
Novartis Investigative Site
Yinchuan, Ningxia, 100039, China
Novartis Investigative Site
Jinan, Shandong, 250021, China
Novartis Investigative Site
Jinan, Shandong, 250022, China
Novartis Investigative Site
Qingdo, Shandong, 266033, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200071, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200072, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200437, China
Novartis Investigative Site
Taiyuan, Shanxi, 030001, China
Novartis Investigative Site
Xian, Shanxi, 710004, China
Novartis Investigative Site
Xi’an, Shanxi, 710061, China
Novartis Investigative Site
Chengdu, Sichuan, 610017, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300192, China
Novartis Investigative Site
Ürümqi, Xinjiang, 830000, China
Novartis Investigative Site
Ürümqi, Xinjiang, 830001, China
Novartis Investigative Site
Wenzhou, Zhejiang, 325000, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100191, China
Novartis Investigative Site
Chongqing, 400011, China
Novartis Investigative Site
Jinan, 250012, China
Novartis Investigative Site
Nanjing, 210042, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Shanyang, 110005, China
Novartis Investigative Site
Tianjin, 300052, China
Novartis Investigative Site
Wuhan, 430022, China
Novartis Investigative Site
Zhejiang, 315016, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 20, 2021
Study Start
September 26, 2021
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
March 20, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share