Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie

About this trial

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.

Risankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.

Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines.

Decision to treat with risankizumab is made prior to and independently of study participation.

Disqualifiers

History of a sleep disorder diagnosis which the patient is currently being treated for.

Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.

Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.

Trial population

Adult participants with moderate to severe plaque psoriasis who are prescribed risankizumab by their physician.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 1 trial group
Group A: Risankizumab

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1

DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no at all) to 1 (a little).

Time frame
At 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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