PsoriasisCORONATENCT05555953
Effect of Long-term Psoriasis on Patients' Life - CORONATE
An observational study of Psoriasis, run by AbbVie at 15 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 543 participants
- Where
- 15 sitesItaly
- Study dates
- 26 Jan 2023to 17 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with moderate-to-severe psoriasis
Who may be able to join
- 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).
Who cannot join
- Participants with psychiatric conditions.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Azienda Ospedaliero Universitaria delle Marche /ID# 245117
Ancona, 60020
A.O.U. Consorziale Policlinico di Bari /ID# 245276
Bari, 70124
ASST degli Spedali Civili di Brescia /ID# 245694
Brescia, 25123
AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569
Florence, Firenze, 50125
Ospedale San Martino /ID# 245641
Genoa, Genova, 16132
Ospedale Villa Scassi /ID# 245445
Genova, 16149
Presidio Ospedaliero San Salvatore /ID# 245618
L’Aquila, L Aquila, 67100
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 245507
Messina, 98125
Azienda Ospedale-Universita Padova /ID# 245115
Padova, 35128
Azienda Ospedaliero-Universitaria di Parma /ID# 244950
Parma, 43126
Ospedale Infermi Di Rimini /ID# 245199
Rimini, 47923
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116
Rome, Roma, 00144
Policlinico Agostino Gemelli /ID# 245570
Rome, Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Sant'Anna /ID# 246438
Turin, Torino, 10126
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 245119
Verona, 37126
About this study
Official title: EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE
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.
Read more
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.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, CORONATE questionnaire
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start26 Jan 2023
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555953
- Sponsor's protocol ID
- H23-093
- Acronym
- CORONATE
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE
- ClinicalTrials.gov ID
- NCT05555953
- Acronym / sponsor ID
- CORONATE / H23-093
- Conditions
- Psoriasis
- Keywords
- Psoriasis, CORONATE questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with moderate-to-severe psoriasis
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants with psychiatric conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CORONATE Questionnaire Score
Time frame: Up to 22 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by AbbVie at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CORONATE Questionnaire Score (time frame: Up to 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.