NCT05555953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 26, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

September 23, 2022

Last Update Submit

October 24, 2024

Conditions

Psoriasis

Keywords

PsoriasisCORONATE questionnaire

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Phase-1

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

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.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with moderate-to-severe psoriasis

You may qualify if:

  • 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).

You may not qualify if:

  • \- Participants with psychiatric conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569

Florence, Firenze, 50125, Italy

Location

Ospedale San Martino /ID# 245641

Genoa, Genova, 16132, Italy

Location

Presidio Ospedaliero San Salvatore /ID# 245618

L’Aquila, L Aquila, 67100, Italy

Location

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

Rome, Roma, 00144, Italy

Location

Policlinico Agostino Gemelli /ID# 245570

Rome, Roma, 00168, Italy

Location

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

Turin, Torino, 10126, Italy

Location

Azienda Ospedaliero Universitaria delle Marche /ID# 245117

Ancona, 60020, Italy

Location

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

Bari, 70124, Italy

Location

ASST degli Spedali Civili di Brescia /ID# 245694

Brescia, 25123, Italy

Location

Ospedale Villa Scassi /ID# 245445

Genova, 16149, Italy

Location

Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507

Messina, 98125, Italy

Location

Azienda Ospedale-Universita Padova /ID# 245115

Padua, 35128, Italy

Location

Azienda Ospedaliero-Universitaria di Parma /ID# 244950

Parma, 43126, Italy

Location

Ospedale Infermi Di Rimini /ID# 245199

Rimini, 47923, Italy

Location

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

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

January 26, 2023

Primary Completion

October 17, 2024

Study Completion

October 17, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

IT(15)