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

Completed

• Conditions: Psoriasis

• Registration Number: NCT05555953
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2023-01-26
• Status Verified: 2024-10
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 543

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CORONATE Questionnaire Score	Up to 22 months	The CORONATE Questionnaire is a self-administered 25 item questionnaire used to assess the long term effect of moderate to severe psoriasis. Scores range from 0 (false) to 3 (true).

Trial Locations

Locations (15)

AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569; 🇮🇹 Florence, Firenze, Italy

Ospedale San Martino /ID# 245641; 🇮🇹 Genoa, Genova, Italy

Policlinico Agostino Gemelli /ID# 245570; 🇮🇹 Rome, Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Sant'Anna /ID# 246438; 🇮🇹 Turin, Torino, Italy

Azienda Ospedaliero Universitaria delle Marche /ID# 245117; 🇮🇹 Ancona, Italy

A.O.U. Consorziale Policlinico di Bari /ID# 245276; 🇮🇹 Bari, Italy

ASST degli Spedali Civili di Brescia /ID# 245694; 🇮🇹 Brescia, Italy

Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507; 🇮🇹 Messina, Italy

Azienda Ospedale-Universita Padova /ID# 245115; 🇮🇹 Padova, Italy

Ospedale Infermi Di Rimini /ID# 245199; 🇮🇹 Rimini, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 245119; 🇮🇹 Verona, Italy

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116; 🇮🇹 Rome, Roma, Italy

Ospedale Villa Scassi /ID# 245445; 🇮🇹 Genova, Italy

Azienda Ospedaliero-Universitaria di Parma /ID# 244950; 🇮🇹 Parma, Italy

Presidio Ospedaliero San Salvatore /ID# 245618; 🇮🇹 L'Aquila, L Aquila, Italy