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Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi) in Adult Participants With Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

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AbbVie

Status

Active, not recruiting

Conditions

Psoriasis
Psoriatic Arthritis

Study type

Observational

Funder types

Industry

Identifiers

NCT04433442
P20-271

Details and patient eligibility

About

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis or psoriatic arthritis and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis. Around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across Korea. The sample size for this study is a requirement by local authorities.

Participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician.

There is expected to be no additional burden for participants in this study. All study visits will occur during routine clinical practice and participants will be followed for 52 weeks.

Enrollment

2,324 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Suitable for the treatment with risankizumab according to the approved local label.
  • Voluntarily agree to participate in this study and sign informed consent.

Exclusion criteria

  • Contraindications to risankizumab as listed on the approved local label.

Trial design

2,324 participants in 1 patient group

Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis
Description:
Participants will receive risankizumab as prescribed by the physician in routine clinical practice.

Trial contacts and locations

64

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Central trial contact

Minje Kim; Celine Im

Data sourced from clinicaltrials.gov

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