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

NCT ID: NCT05555953

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

543 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-26

Study Completion Date

2024-10-17

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Phase-1

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

No interventions assigned to this group

Phase-2

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569

Florence, Firenze, Italy

Site Status

Ospedale San Martino /ID# 245641

Genoa, Genova, Italy

Site Status

Presidio Ospedaliero San Salvatore /ID# 245618

L’Aquila, L Aquila, Italy

Site Status

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116

Rome, Roma, Italy

Site Status

Policlinico Agostino Gemelli /ID# 245570

Rome, Roma, Italy

Site Status

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Sant'Anna /ID# 246438

Turin, Torino, Italy

Site Status

Azienda Ospedaliero Universitaria delle Marche /ID# 245117

Ancona, , Italy

Site Status

A.O.U. Consorziale Policlinico di Bari /ID# 245276

Bari, , Italy

Site Status

ASST degli Spedali Civili di Brescia /ID# 245694

Brescia, , Italy

Site Status

Ospedale Villa Scassi /ID# 245445

Genova, , Italy

Site Status

Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507

Messina, , Italy

Site Status

Azienda Ospedale-Universita Padova /ID# 245115

Padua, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Parma /ID# 244950

Parma, , Italy

Site Status

Ospedale Infermi Di Rimini /ID# 245199

Rimini, , Italy

Site Status

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 245119

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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H23-093

Identifier Type: -

Identifier Source: org_study_id

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