Clinical trial NCT04818385: Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan
Official title: Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis
Risankizumab
Skyrizi
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate to severe plaque psoriasis.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90
timeFrame: Week 24
Secondary outcomes:
measure: Time of First Treatment Change
timeFrame: Up to Week 108
measure: The Percentage of Participants who Achieved PASI 75
timeFrame: Up to Week 108
measure: The Percentage of Participants who Achieved PASI 90
timeFrame: Up to Week 108
measure: The Percentage of Participants who Achieved PASI 100
timeFrame: Up to Week 108
measure: Percentage of Participants who Achieved Absolute PASI<=5
timeFrame: Up to Week 108
measure: Percentage of Participants who Achieved Absolute PASI<=3
timeFrame: Up to Week 108
measure: Percentage of Participants who Achieved Absolute PASI<=1
timeFrame: Up to Week 108
measure: The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1
timeFrame: Up to Week 108
measure: Time to Achieved PASI 75
timeFrame: Up to Week 108
measure: Time to Achieved PASI 100
timeFrame: Up to Week 108
measure: Time to Achieved PASI 90
timeFrame: Up to Week 108
measure: The Percentage of Participants who Achieved PASI 90 at 24 Weeks and Maintained the Response Without Changing the Indicated Dose or Dosing Interval
timeFrame: Up to Week 108
measure: Change from Baseline in PASI
timeFrame: Up to Week 108
measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
timeFrame: Up to Week 108
measure: Change from Baseline in DLQI
timeFrame: Up to Week 108
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Week 108
measure: Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy
timeFrame: Up to 5 years Medical Chart Review Prior to Enrollment
measure: Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy
timeFrame: Up to 5 years Medical Chart Review Prior to Enrollment
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 230017
state: Taipei
city: Hsinchu City
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch /ID# 238432
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital /ID# 238431
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 229961
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 253776
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 230018
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 253775
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: