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CompletedNCT05555953CORONATEUpdated Oct 26, 2024

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

An observational study in Psoriasis, sponsored by AbbVie. Completed at 15 sites in Italy. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
543
Ages
30 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
  • CORONATE questionnaire
03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 543 is above the median of 200 across 400 observational studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

AbbVie is the lead sponsor of 969 studies on the registry; 134 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with moderate-to-severe psoriasis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

- Participants with psychiatric conditions.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
543 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

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).

    Time frame: Up to 22 months

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Study locations

15 sites
  • AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569
    Florence, Firenze 50125, Italy
  • Ospedale San Martino /ID# 245641
    Genoa, Genova 16132, Italy
  • Presidio Ospedaliero San Salvatore /ID# 245618
    L’Aquila, L Aquila 67100, Italy
  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116
    Rome, Roma 00144, Italy
  • Policlinico Agostino Gemelli /ID# 245570
    Rome, Roma 00168, Italy
  • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Sant'Anna /ID# 246438
    Turin, Torino 10126, Italy
  • Azienda Ospedaliero Universitaria delle Marche /ID# 245117
    Ancona, 60020, Italy
  • A.O.U. Consorziale Policlinico di Bari /ID# 245276
    Bari, 70124, Italy
  • ASST degli Spedali Civili di Brescia /ID# 245694
    Brescia, 25123, Italy
  • Ospedale Villa Scassi /ID# 245445
    Genova, 16149, Italy
  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507
    Messina, 98125, Italy
  • Azienda Ospedale-Universita Padova /ID# 245115
    Padova, 35128, Italy
  • Azienda Ospedaliero-Universitaria di Parma /ID# 244950
    Parma, 43126, Italy
  • Ospedale Infermi Di Rimini /ID# 245199
    Rimini, 47923, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 245119
    Verona, 37126, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05555953
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Sep 27, 2022
Start date
Jan 26, 2023
Primary completion
Oct 17, 2024
Completion
Oct 17, 2024
Last update
Oct 26, 2024

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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