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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04894890
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Arms & Interventions

Arms

: secukinumab

Patients administered secukinumab by prescription

Interventions

Drug: - secukinumab

There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Xicheng Direct, Beijing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Xicheng Direct, Beijing, 100044

Novartis Investigative Site, Chongqing, Chongqing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Chongqing, Chongqing, 400010

Novartis Investigative Site, Lanzhou, Gansu, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Lanzhou, Gansu, 730030

Novartis Investigative Site, Guangzhou, Guangdong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Guangzhou, Guangdong, 510000

Novartis Investigative Site, Shen Zhen, Guangdong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shen Zhen, Guangdong, 518116

Novartis Investigative Site, Shenzhen, Guangdong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shenzhen, Guangdong, 518020

Novartis Investigative Site, Guangdong, Guangzhou, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Guangdong, Guangzhou, 510091

Novartis Investigative Site, Haikou, Hainan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Haikou, Hainan, 571127

Novartis Investigative Site, Handan, Hebei, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Handan, Hebei, 056002

Novartis Investigative Site, Zhengzhou, Henan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Zhengzhou, Henan, 450003

Novartis Investigative Site, Wuhan, Hubei, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Wuhan, Hubei, 430030

Novartis Investigative Site, Changsha City, Hunan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Changsha City, Hunan, 410011

Novartis Investigative Site, Changsha, Hunan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Changsha, Hunan, 410003

Novartis Investigative Site, Suzhou, Jiangsu, China

Status

Recruiting

Address

Novartis Investigative Site

Suzhou, Jiangsu, 215006

Novartis Investigative Site, Xuzhou, Jiangsu, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Xuzhou, Jiangsu, 221003

Novartis Investigative Site, Changchun, Jilin, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Changchun, Jilin, 130041

Novartis Investigative Site, Yinchuan, Ningxia, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Yinchuan, Ningxia, 100039

Novartis Investigative Site, Jinan, Shandong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Jinan, Shandong, 250021

Novartis Investigative Site, Jinan, Shandong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Jinan, Shandong, 250022

Novartis Investigative Site, Qingdo, Shandong, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Qingdo, Shandong, 266033

Novartis Investigative Site, Shanghai, Shanghai, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shanghai, Shanghai, 200071

Novartis Investigative Site, Shanghai, Shanghai, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shanghai, Shanghai, 200072

Novartis Investigative Site, Shanghai, Shanghai, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shanghai, Shanghai, 200437

Novartis Investigative Site, Taiyuan, Shanxi, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Taiyuan, Shanxi, 030001

Novartis Investigative Site, XI An, Shanxi, China

Status

Active, not recruiting

Address

Novartis Investigative Site

XI An, Shanxi, 710061

Novartis Investigative Site, Xian, Shanxi, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Xian, Shanxi, 710004

Novartis Investigative Site, Chengdu, Sichuan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Chengdu, Sichuan, 610017

Novartis Investigative Site, Chengdu, Sichuan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Chengdu, Sichuan, 610041

Novartis Investigative Site, Tianjin, Tianjin, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Tianjin, Tianjin, 300192

Novartis Investigative Site, Urumqi, Xinjiang, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Urumqi, Xinjiang, 830000

Novartis Investigative Site, Urumqi, Xinjiang, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Urumqi, Xinjiang, 830001

Novartis Investigative Site, Wenzhou, Zhejiang, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Wenzhou, Zhejiang, 325000

Novartis Investigative Site, Beijing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Beijing, , 100034

Novartis Investigative Site, Beijing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Beijing, , 100191

Novartis Investigative Site, Chongqing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Chongqing, , 400011

Novartis Investigative Site, Jinan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Jinan, , 250012

Novartis Investigative Site, Nanjing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Nanjing, , 210042

Novartis Investigative Site, Shanghai, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shanghai, , 200025

Novartis Investigative Site, Shanyang, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Shanyang, , 110005

Novartis Investigative Site, Tianjin, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Tianjin, , 300052

Novartis Investigative Site, Wuhan, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Wuhan, , 430022

Novartis Investigative Site, Zhejiang, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Zhejiang, , 315016

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