Effect of Long-term Psoriasis on Patients' Life - CORONATE

AbbVie

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT05555953

H23-093

Details and patient eligibility

About

Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants.

Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months.

There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.

Enrollment: 543 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI<10 with involvement of sensitive areas) since at least 10 years.
• Adult partner in relationship with the participant since at least 3 years(Part 2 only).

Exclusion criteria

• Participants with psychiatric conditions.

Trial design

543 participants in 2 patient groups

Phase-1

Description:

The draft CORONATE questionnaire will be administered to participants to create the final version of the questionnaire.

Phase-2

Description:

The questionnaire created in Phase 1 will be administered to a new group of participants for validation. All partners who are in a relationship with the participants since at least 3 years will be asked to participate in the study for the comparison between participants' and partners' perspectives on the impact of long-term psoriasis on participants' life.