Clinical trial NCT05555953: Effect of Long-term Psoriasis on Patients' Life - CORONATE
Official title: EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
CORONATE questionnaire
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 543
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate-to-severe psoriasis

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CORONATE Questionnaire Score
timeFrame: Up to 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569
state: Firenze
city: Genoa
country: Italy
facility: Ospedale San Martino /ID# 245641
state: Genova
city: L'Aquila
country: Italy
facility: Presidio Ospedaliero San Salvatore /ID# 245618
state: L Aquila
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116
state: Roma
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 245570
state: Roma
city: Turin
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Sant'Anna /ID# 246438
state: Torino
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 245117
city: Bari
country: Italy
facility: A.O.U. Consorziale Policlinico di Bari /ID# 245276
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 245694
city: Genova
country: Italy
facility: Ospedale Villa Scassi /ID# 245445
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507
city: Padova
country: Italy
facility: Azienda Ospedale-Universita Padova /ID# 245115
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma /ID# 244950
city: Rimini
country: Italy
facility: Ospedale Infermi Di Rimini /ID# 245199
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 245119
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: