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

Psoriasis Clinical Trial

— UNMASK2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894890
• Other study ID #: CAIN457ACN06
• Status: Completed
• Start date: September 26, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Changsha City	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Guangdong	Guangzhou
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Haikou	Hainan
China	Novartis Investigative Site	Handan	Hebei
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Jinan
China	Novartis Investigative Site	Lanzhou	Gansu
China	Novartis Investigative Site	Nanjing
China	Novartis Investigative Site	Qingdo	Shandong
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanyang
China	Novartis Investigative Site	Shen Zhen	Guangdong
China	Novartis Investigative Site	Shenzhen	Guangdong
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Taiyuan	Shanxi
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Urumqi	Xinjiang
China	Novartis Investigative Site	Urumqi	Xinjiang
China	Novartis Investigative Site	Wenzhou	Zhejiang
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wuhan
China	Novartis Investigative Site	XI An	Shanxi
China	Novartis Investigative Site	Xian	Shanxi
China	Novartis Investigative Site	Xicheng Direct	Beijing
China	Novartis Investigative Site	Xuzhou	Jiangsu
China	Novartis Investigative Site	Yinchuan	Ningxia
China	Novartis Investigative Site	Zhejiang
China	Novartis Investigative Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients experiencing a 75% reduction of PASI (PASI75)	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 4, week12, week 16, week 24, week 36, week 52
Secondary	Percentage of patients experiencing a 90% reduction of PASI (PASI90)	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 4, week12, week 16, week 36, week 52
Secondary	Percentage of patients experiencing a 100% reduction of PASI (PASI100)	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 4, week12, week 16, week 24, week 36, week 52
Secondary	Percentage of patients with absolute PASI change =1, =2, =3,and =5	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 4, week12, week 16, week 24, week 36, week 52
Secondary	Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1	The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)	week 4, week12, week 16, week 24, week 36, week 52
Secondary	Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)	The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)	week 4, week12, week 16, week 24, week 36, week 52
Secondary	Percentage of patients achieved (Body Surface Area) BSA=1%	The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs.; The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.	week 4, week12, week 16, week 24, week 36, week 52
Secondary	Mean change in Dermatology life quality index (DLQI)	DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.; Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.; Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.	Baseline,week 4, week12, week 16, week 24, week 36, week 52
Secondary	Percentage of patients achieving DLQI 0 or 1 response	DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.; Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.; Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.	week 4, week12, week 16, week 24, week 36, week 52
Secondary	Incidence of AEs/SAEs	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.; Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Secondary	Incidence of treatment-related AEs on-treatment and post-discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Secondary	Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.; Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Secondary	Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up	Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant	52 weeks
Secondary	Incidence of AEs of special interest on-treatment and post discontinuation follow up	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Secondary	Proportion of patients experiencing at least one AE	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Secondary	Average number of AEs per patient	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Secondary	Percentage of secukinumab discontinuation caused by AE	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	52 weeks
Secondary	Frequency distribution of patients by dosing pattern	Frequency distribution of patients by dosing pattern will be collected	52 weeks
Secondary	Frequency distribution of patients by secukinumab retention	Percentage of patients who are persistent secukinumab users or who discontinue secukinumab	Week 4, week 12, week 16, week 24, week 36 and week 52
Secondary	Mean (SD) time to secukinumab discontinuation	Mean (SD) time to secukinumab discontinuation will be collected	Up to 52 weeks
Secondary	Median (interquartile range) time to secukinumab discontinuation	Median (IQR) time to secukinumab discontinuation will be collected	52 weeks