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

Study Identifier
P20-272
CT.gov Identifier
NCT04818385
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    National Taiwan University Hospital /ID# 230017
    Taipei City, Taipei, Taiwan, 100
    Status
    Not applicable
    Location
    National Taiwan University Hospital - Hsinchu branch /ID# 238432
    Hsinchu, Taiwan, 30059
    Status
    Not applicable
    Location
    Hualien Tzu Chi Hospital /ID# 238431
    Hualien City, Taiwan, 97002
    Status
    Not applicable
    Location
    Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016
    Kaohsiung City, Taiwan, 807
    Status
    Not applicable
    Location
    China Medical University Hospital /ID# 229961
    Taichung, Taiwan, 40447
    Status
    Not applicable
    Location
    National Cheng Kung University Hospital /ID# 253776
    Tainan, Taiwan, 704
    Status
    Not applicable
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