Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan

Psoriasis Clinical Trial

Official title:

Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818385
• Other study ID #: P20-272
• Status: Recruiting
• Start date: May 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past.

Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan.

Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist t at the time of recruitment.

• Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.

• Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan.

Exclusion Criteria:

• Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital - Hsinchu branch /ID# 238432	Hsinchu City
Taiwan	Hualien Tzu Chi Hospital /ID# 238431	Hualien City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016	Kaohsiung
Taiwan	China Medical University Hospital /ID# 229961	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 253776	Tainan
Taiwan	National Taiwan University Hospital /ID# 230017	Taipei City
Taiwan	Taipei Medical University Hospital /ID# 230018	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 253775	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Week 24
Secondary	Time of First Treatment Change	Time of first treatment change is defined as any treatment change including discontinuation, dose escalation and dosing interval shortening.	Up to Week 108
Secondary	The Percentage of Participants who Achieved PASI 75	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	The Percentage of Participants who Achieved PASI 90	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	The Percentage of Participants who Achieved PASI 100	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	Percentage of Participants who Achieved Absolute PASI<=5	The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.	Up to Week 108
Secondary	Percentage of Participants who Achieved Absolute PASI<=3	The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.	Up to Week 108
Secondary	Percentage of Participants who Achieved Absolute PASI<=1	The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.	Up to Week 108
Secondary	The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1	DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired.	Up to Week 108
Secondary	Time to Achieved PASI 75	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	Time to Achieved PASI 100	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	Time to Achieved PASI 90	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	The Percentage of Participants who Achieved PASI 90 at 24 Weeks and Maintained the Response Without Changing the Indicated Dose or Dosing Interval	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	Change from Baseline in PASI	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to Week 108
Secondary	Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis	BSA affected by psoriasis as assessed by the Investigator.	Up to Week 108
Secondary	Change from Baseline in DLQI	DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired.	Up to Week 108
Secondary	Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.	Up to Week 108
Secondary	Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy	The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.	Up to 5 years Medical Chart Review Prior to Enrollment
Secondary	Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy	The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Up to 5 years Medical Chart Review Prior to Enrollment

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