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

Psoriasis Clinical Trial

— CORONATE  

Official title:

EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555953
• Other study ID #: H23-093
• Status: Recruiting
• Start date: January 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 245276	Bari
Italy	ASST Spedali civili di Brescia /ID# 245694	Brescia
Italy	Ospedale Piero Palagi /ID# 245569	Florence
Italy	Ospedale Policlinico San Martino /ID# 245641	Genoa	Genova
Italy	Ospedale Villa Scassi /ID# 245445	Genova
Italy	Presidio Ospedaliero San Salvatore /ID# 245618	L'Aquila	L Aquila
Italy	Azienda Ospedaliera Universitaria Di Messina G. Martino /ID# 245507	Messina
Italy	Azienda Ospedaliera di Padova /ID# 245115	Padova
Italy	Azienda Ospedaliero-Universitaria di Parma /ID# 244950	Parma
Italy	Ospedale Infermi di Rimini /ID# 245199	Rimini
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 245570	Rome	Lazio
Italy	IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116	Rome	Roma
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 245117	Torette	Ancona
Italy	A.O.U. Città della Salute e della Scienza di Torino/Ospedale San'Anna /ID# 246438	Turin	Torino
Italy	Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Trento /ID# 245119	Verona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CORONATE Questionnaire Score	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).	Up to 22 months